tag:blogger.com,1999:blog-46481558436889518492024-03-12T18:24:22.543-07:00FDA RegulationsProvide latest FDA regulations updateFDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.comBlogger39125tag:blogger.com,1999:blog-4648155843688951849.post-38735791866897661812023-05-19T11:11:00.000-07:002023-05-19T11:11:00.982-07:00Do I need FDA registration if I am ISO certified?<p> Yes, obtaining ISO certification does not exempt you from
the requirement of FDA registration if your products or business activities
fall under the regulatory purview of the U.S. Food and Drug Administration
(FDA).</p><p class="MsoNormal"><o:p></o:p></p>
<p class="MsoNormal">ISO certification, specifically ISO 9001, is a globally
recognized standard for quality management systems and focuses on ensuring
consistent quality in processes and products. It demonstrates that a company
has implemented effective quality management practices.<o:p></o:p></p>
<p class="MsoNormal">On the other hand, FDA registration is required for certain
types of businesses, products, or activities that the FDA regulates. These may
include medical devices, pharmaceuticals, food and beverages, cosmetics,
dietary supplements, and other products falling under FDA jurisdiction. FDA
registration is separate from ISO certification and is specific to the U.S.
market.<o:p></o:p></p>
<p class="MsoNormal">While <a href="https://www.iso-certification.us/" target="_blank">ISO certification</a> can be beneficial and help
demonstrate your commitment to quality, it does not fulfill the specific
regulatory requirements set by the FDA. If your products or business activities
require FDA oversight, you would need to comply with FDA regulations, which may
involve registering your facilities, submitting appropriate documentation, and
adhering to specific manufacturing and labeling requirements.<o:p></o:p></p>
<h2 style="text-align: left;"><b><u>What exact benefit does ISO 9001 provide for a
facility for FDA registration?</u></b></h2>
<p class="MsoNormal">ISO 9001 certification is not a requirement for FDA
registration; it can provide several benefits for a facility seeking <a href="https://www.fdahelp.us/" target="_blank">FDA registration</a>. Here are some specific advantages:<o:p></o:p></p>
<ol start="1" style="margin-top: 0in;" type="1">
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Enhanced
Quality Management: ISO 9001 sets forth a framework for implementing and
maintaining a robust quality management system (QMS). By adopting ISO
9001, a facility can establish well-defined processes, procedures, and
documentation that promote consistency, efficiency, and adherence to
quality standards. This can contribute to improved product quality and
regulatory compliance, which are essential for FDA registration.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Compliance
Readiness: ISO 9001 requires organizations to identify and comply with
applicable regulatory requirements. This aligns well with FDA regulations
and can help a facility prepare for FDA inspections and audits.
Implementing ISO 9001 can enable the facility to proactively address
compliance issues, reduce the likelihood of non-compliance, and demonstrate
a commitment to quality and regulatory requirements.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Continuous
Improvement: ISO 9001 emphasizes a culture of continuous improvement
within an organization. By implementing a system for ongoing monitoring,
measurement, analysis, and improvement of processes, the facility can
identify areas for enhancement, mitigate risks, and optimize its
operations. This proactive approach to quality management can lead to
increased efficiency, reduced errors, and improved overall performance,
which are valued attributes for FDA registration.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Customer
Confidence: <a href="https://www.iso-certification.us/iso-9001-certificate.html" target="_blank">ISO 9001 certification</a> signifies a facility's commitment to
delivering high-quality products and services. This can instill confidence
in customers and stakeholders, including the FDA. The certification acts
as evidence that the facility follows internationally recognized quality
standards, which can positively influence the perception of the facility's
capabilities and reliability.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Competitive
Advantage: ISO 9001 certification can provide a competitive edge for a
facility seeking FDA registration. Many customers, including FDA
regulators, consider ISO 9001 certification as a valuable criterion when
evaluating suppliers or partners. By holding ISO 9001 certification, the
facility can differentiate itself from competitors, demonstrate its
commitment to quality, and enhance its reputation.<o:p></o:p></li>
</ol>
<p class="MsoNormal">While ISO 9001 does not directly impact FDA registration,
the benefits it offers can contribute to the overall readiness and performance
of a facility, which can positively influence the FDA registration process. It
is important to note that FDA registration requirements extend beyond ISO 9001
compliance, as the FDA has its own specific regulations and guidelines that
must be followed.<o:p></o:p></p>
<p class="MsoNormal"><span style="mso-spacerun: yes;"> </span><o:p></o:p></p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-16016450758454429802023-05-04T13:09:00.002-07:002023-05-04T13:09:58.485-07:00Why I need a consultant for the FDA 510 K submission?<p>Submitting a 510(k) premarket notification to the US Food
and Drug Administration (FDA) can be a complex process that requires a thorough
understanding of the FDA's regulations and requirements. While it is possible
to prepare and submit a 510(k) on your own, many companies choose to work with an
FDA 510 K consultant for the following reasons:</p><p class="MsoNormal"><o:p></o:p></p>
<ol start="1" style="margin-top: 0in;" type="1">
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Expertise:
An <a href="https://www.fdahelp.us/fda-510k/us-fda-510k-consultant.html" target="_blank"><b>FDA 510(k) consultant</b></a> has specialized knowledge and experience in navigating
the FDA's regulations and requirements. They can provide guidance and
advice on how to prepare a successful submission that meets all of the
FDA's requirements.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Efficiency:
Working with a consultant can help to streamline the submission process
and reduce the time and resources required to prepare and submit a 510(k).
Consultants can provide templates, checklists, and other tools to help ensure
the submission is complete and accurate.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Risk
mitigation: An FDA 510(k) consultant can help identify potential risks and
issues with the submission and provide guidance on how to address these
risks and issues before submitting to the FDA. This can reduce the
likelihood of rejection or delay in the <a href="https://www.fdahelp.us/fda-approval.html">FDA approval</a> process.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Accountability:
Working with a consultant can provide a level of accountability and
assurance that the submission is prepared correctly and meets all of the
FDA's requirements. Consultants can also provide ongoing support and
guidance throughout the approval process.<o:p></o:p></li>
</ol>
<p class="MsoNormal">In summary, while it is possible to prepare and submit a
510(k) on your own, working with a consultant can provide expertise,
efficiency, risk mitigation, and accountability throughout the submission
process.<o:p></o:p></p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-41446701551298379202023-05-03T21:47:00.001-07:002023-05-03T21:47:14.295-07:00Importance of Quality Manual in ISO 9001 Certification<p>The Quality Manual is one of the mandatory documents
required for ISO 9001 certification. It describes the organization's quality
policy, objectives, scope, processes, and procedures, including the roles and
responsibilities of personnel involved in the QMS. It also includes information
on the organization's quality objectives, how they are measured, and the
processes in place to continually improve the QMS.</p><p class="MsoNormal"><o:p></o:p></p>
<p class="MsoNormal">Here are some key benefits of having a Quality Manual as
part of your <a href="https://www.iso-certification.us/" target="_blank"><b>ISO 9001 certification</b></a>:<o:p></o:p></p>
<ol start="1" style="margin-top: 0in;" type="1">
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Provides
clarity and consistency: The Quality Manual provides a clear, concise, and
standardized approach to managing quality across the organization. This
helps to ensure consistency in the implementation of the QMS, and can help
reduce errors and inconsistencies in processes.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Improves
communication: The <a href="https://www.iso-certification.us/quality-manual.html" target="_blank"><b>Quality Manual</b></a> serves as a key reference document for
all stakeholders involved in the QMS, including employees, customers, and
auditors. By providing a clear description of the organization's quality
policy, objectives, and procedures, the Quality Manual can improve
communication and understanding of the QMS.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Demonstrates
commitment to quality: By documenting its QMS in a Quality Manual, an
organization can demonstrate its commitment to quality to both internal and
external stakeholders. This can help to build trust and confidence in the
organization's products and services and can provide a competitive
advantage.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Facilitates
continuous improvement: The Quality Manual includes information on how the
organization measures its quality objectives and processes, and how it
identifies and addresses areas for improvement. This helps to facilitate a
culture of continuous improvement, which is essential for maintaining <a href="https://www.libertymanagement.us/iso-9001-certification/" target="_blank">ISO 9001 certification</a>.<o:p></o:p></li>
</ol>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-88551258964111209442023-05-03T21:36:00.001-07:002023-05-03T21:36:18.421-07:00How To Get FDA Registration Number?<p><b>FDA Registration Number for Food Facility </b></p><p>To obtain an <a href="https://www.fdahelp.us/fda-registration-number-search.html"><b>FDA registration number </b></a>for your food facility,
you will need to follow these steps:</p><p class="MsoNormal"><o:p></o:p></p>
<ol start="1" style="margin-top: 0in;" type="1">
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Determine
if you need to register: The FDA requires that all domestic and foreign
facilities that manufacture, process, pack, or hold food for consumption in
the United States register with the FDA. Some facilities are exempt from
registration, so make sure to check if you qualify for an exemption.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Create
an FDA account: You will need to create an account with the FDA's Food
Facility Registration Module (FFRM) in order to register your facility.
You can do this on the FDA's website.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Complete
the registration form: Once you have created an account, you will need to
complete the registration form. This includes providing information about
your facility, such as its name, address, and contact information.<o:p></o:p></li>
<li class="MsoNormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;">Submit
your registration: Once you have completed the registration form and paid
the fee, you can submit your registration to the FDA. Your registration
will be reviewed, and you will receive an FDA registration number once
your registration has been approved.<o:p></o:p></li>
</ol>
<p class="MsoNormal">It's important to note that <a href="https://www.fdahelp.us/fda-food-registration.html" target="_blank">FDA food facility registrations</a>
must be renewed every other year, and any changes to your facility or contact
information must be updated in a timely manner.<o:p></o:p></p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-51910273130986930352023-05-03T21:28:00.000-07:002023-05-03T21:28:27.262-07:00Benefits of FDA Food Facility Registration<br /><br />There are several benefits to FDA food facility registration, including:<br /><br /><ol style="text-align: left;"><li><span style="text-align: justify;">Compliance with federal regulations: </span><a href="https://www.libertymanagement.us/fda-registration-food-facility/" style="text-align: justify;">FDA food facility registration</a><span style="text-align: justify;"> is mandatory for food facilities that manufacture, process, pack, or hold food for consumption in the United States. By registering with the FDA, food facilities can ensure that they are in compliance with federal regulations.</span></li><li style="text-align: justify;">Improved food safety: The FDA uses the information provided during the registration process to track the location and activities of food facilities. This allows the FDA to respond quickly in the event of a food safety issue, reducing the risk of illness or injury to consumers.</li><li style="text-align: justify;">Increased consumer confidence: Consumers are becoming increasingly aware of food safety issues, and many are seeking products made by facilities <a href="https://www.fdahelp.us/register-fda.html">registered with the FDA</a>. By registering with the FDA, food facilities can demonstrate their commitment to food safety and increase consumer confidence in their products.</li><li style="text-align: justify;">Access to international markets: Many countries require that food facilities be registered with the FDA in order to export food products to the United States. By registering with the FDA, food facilities can access international markets and increase their potential customer base.</li><li style="text-align: justify;">Reduced inspection delays: Registered food facilities are subject to inspection by the FDA, but registration allows the FDA to better plan and prioritize inspections. This can reduce delays and help food facilities avoid costly production shutdowns.</li></ol>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-58273659832024898702023-03-14T09:43:00.001-07:002023-03-14T09:46:26.245-07:00NDC Number<p> <b><a href="https://www.fdahelp.us/fda-labeler-code.html">How to get NDC Number?</a></b></p><p>NDC number is a 10-digit code that represents the labeler+drug+package size. the first 5 digits represent the labeler (the company) which is assigned by US FDA. the second segment represents the drug product and is assigned by the labeler. the third segment is for packaging type and size, which is also assigned by the labeler. There is no pre-assigned NDC number database on the FDA site; it is the labeler's responsibility to assign the 10-digit NDC number and maintain traceability.</p><div class="separator" style="clear: both; text-align: justify;"><a href="https://www.fdahelp.us/fda-labeler-code.html"><iframe allowfullscreen='allowfullscreen' webkitallowfullscreen='webkitallowfullscreen' mozallowfullscreen='mozallowfullscreen' width='583' height='256' src='https://www.blogger.com/video.g?token=AD6v5dy2ttT0Y6zySiewYAsu9RzuVS7nq3jwBdAXyDtQtg4nc1eo4rL_csb0UcH3EXQp3GwXDLTvrDBd9trMd0SxUA' class='b-hbp-video b-uploaded' frameborder='0'></iframe><br /></a></div><br /><p>information required for NDC number request are</p><h1 class="h1tag" style="background-color: white; border: none; box-sizing: border-box; color: #565051; font-family: Verdana, Arial, "Times New Roman"; font-size: 12px; line-height: 19px; margin-block-start: 0.67em; margin-bottom: 16px !important; margin-left: 0px; margin-right: 0px; margin-top: 0px; margin: 0px 0px 16px; padding-bottom: 3px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">Informations required for NDC Number request</strong></h1><ul style="background-color: white; box-sizing: border-box; color: #313131; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin-bottom: 1rem; margin-top: 0px; padding-inline-start: 15px;"><li style="box-sizing: border-box; font-size: 16px; line-height: 24px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">Labeler Name</strong></li><p style="box-sizing: border-box; font-size: 16px; line-height: 24px; margin-block: 1em; margin-bottom: 1rem; margin-top: 0px; text-align: justify;"></p><li style="box-sizing: border-box; font-size: 16px; line-height: 24px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">DUNS Number</strong></li><p style="box-sizing: border-box; font-size: 16px; line-height: 24px; margin-block: 1em; margin-bottom: 1rem; margin-top: 0px; text-align: justify;"> FDA uses the DUNS number to verify the establishment address.</p><li style="box-sizing: border-box; font-size: 16px; line-height: 24px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">Contact Name & Address</strong></li><p style="box-sizing: border-box; font-size: 16px; line-height: 24px; margin-block: 1em; margin-bottom: 1rem; margin-top: 0px; text-align: justify;"> The address includes Street, City, State, Postal code, Country, Phone, and email.</p><li style="box-sizing: border-box; font-size: 16px; line-height: 24px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">Labeler Address</strong></li><p style="box-sizing: border-box; font-size: 16px; line-height: 24px; margin-block: 1em; margin-bottom: 1rem; margin-top: 0px; text-align: justify;"> Address of the labeler, including Street, City, State, Postal code, and Country.</p><li style="box-sizing: border-box; font-size: 16px; line-height: 24px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">Business Operation</strong></li><p style="box-sizing: border-box; font-size: 16px; line-height: 24px; margin-block: 1em; margin-bottom: 1rem; margin-top: 0px; text-align: justify;"> Identify the Type of business.</p><li style="box-sizing: border-box; font-size: 16px; line-height: 24px;"><strong style="box-sizing: border-box; color: #106297; font-size: 20px; line-height: 24px;">Us Agent</strong></li><p style="box-sizing: border-box; font-size: 16px; line-height: 24px; margin-block: 1em; margin-bottom: 1rem; margin-top: 0px; text-align: justify;"> Each foreign establishment should have a US agent.</p></ul><div style="text-align: justify;"><span face="Arial, Helvetica, sans-serif" style="color: #313131;">Source : </span><span style="text-align: left;"><span face="Arial, Helvetica, sans-serif" style="color: #313131;"><a href="https://www.fdahelp.us/ndc_number.html ">https://www.fdahelp.us/ndc_number.html </a></span></span></div>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-84327093924853391392023-03-14T09:24:00.002-07:002023-03-14T09:24:32.795-07:00FDA Registration Number Search<p> <b><a href="https://www.fdahelp.us/fda-registration-number-search.html" target="_blank">How to search FDA registration number?</a></b></p><p>FDA registration number is an identifier FDA assign to food, drug, and medical device establishment after completing establishment/facility registration.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://www.fdahelp.us/fda-registration-number-search.html"><iframe allowfullscreen='allowfullscreen' webkitallowfullscreen='webkitallowfullscreen' mozallowfullscreen='mozallowfullscreen' width='320' height='266' src='https://www.blogger.com/video.g?token=AD6v5dwfmXN5sghAJmhb2qlJX9DI0kA82AP21zQWiIGABxqZW1SNT0mngVHdvvtsfSF6qt0odx1H5tLXoLoFUlVGNg' class='b-hbp-video b-uploaded' frameborder='0'></iframe></a></div><br /><p>Food facilities, both domestic and foreign, will receive an FDA registration number immediately after completing the registration. For drug and medical device establishments, FDA will assign the registration number later. FDA registration number is a mandatory requirement in issuing prior notice for exporting food products to the USA.</p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-87105903089518875212023-02-27T09:42:00.002-08:002023-02-27T09:42:58.681-08:00Do I need an iso 9001 certificate?<p> ISO 9001 is a quality management standard that outlines the requirements for a quality management system (QMS) and is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements.</p><p><br /></p><p>Having an <a href="https://www.iso-certification.us/iso-9001-certificate.html">ISO 9001 certificate</a> is not mandatory for all businesses, but some organizations may choose to pursue certification as it can demonstrate their commitment to quality and customer satisfaction. ISO 9001 certification can also help organizations improve their operations and processes, reduce costs, and enhance their reputation.</p><p><br /></p><p>Whether or not your business needs an ISO 9001 certificate depends on a variety of factors, such as the industry you operate in, the specific requirements of your customers, and the level of regulatory oversight in your sector. Some industries, such as aerospace, automotive, and medical devices, may have specific regulations or customer requirements that make ISO 9001 certification more relevant and valuable.</p><p><br /></p><p>Ultimately, the decision to pursue <a href="https://www.iso-certification.us/index.html" target="_blank">ISO 9001 certification</a> is up to each individual organization and should be based on a careful evaluation of the benefits and costs involved. It is important to note that obtaining certification can be a significant investment of time, resources, and money, and should be approached as a strategic decision that aligns with your organization's goals and objectives.</p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-37396560994895418142023-02-23T22:03:00.002-08:002023-02-23T22:03:33.738-08:00How to choose an ISO consultant<p> </p><p class="MsoNormal">Choosing an <a href="https://www.iso-certification.us/iso-9001-consultant.html" target="_blank">ISO consultant</a> can be a critical decision for an
organization, as the consultant will help guide the organization through the
process of implementing an ISO management system standard, such as ISO 9001,
ISO 13485, or ISO 45001. Here are some factors to consider when choosing an ISO
consultant:<o:p></o:p></p>
<p class="MsoNormal">1.<span style="mso-tab-count: 1;"> </span>Experience
and expertise: Look for a consultant who has experience in your industry and
has successfully guided other organizations through the ISO certification
process. The consultant should also have a deep understanding of the ISO
standard(s) you are seeking certification for.<o:p></o:p></p>
<p class="MsoNormal">2.<span style="mso-tab-count: 1;"> </span>Communication
skills: The consultant should be able to communicate effectively with your organization's
stakeholders and employees, including explaining technical concepts in a clear
and understandable manner.<o:p></o:p></p>
<p class="MsoNormal">3.<span style="mso-tab-count: 1;"> </span>References
and testimonials: Ask for references and testimonials from the consultant's
previous clients to get a sense of their track record and client satisfaction.<o:p></o:p></p>
<p class="MsoNormal">4.<span style="mso-tab-count: 1;"> </span>Fees and
pricing: Consider the consultant's fees and pricing structure, and make sure
you have a clear understanding of what services are included in the price.<o:p></o:p></p>
<p class="MsoNormal">5.<span style="mso-tab-count: 1;"> </span>Cultural
fit: Look for a consultant who understands and aligns with your organization's
culture and values, as this can help ensure a smooth implementation process.<o:p></o:p></p>
<p class="MsoNormal">6.<span style="mso-tab-count: 1;"> </span>Support
services: Ask about the consultant's availability for ongoing support and
assistance after the implementation process is complete.<o:p></o:p></p>
<p class="MsoNormal">By considering these factors, an organization can choose an
ISO consultant who will help them achieve their <a href="https://www.iso-certification.us/" target="_blank">ISO certification</a> goals and
drive continuous improvement in their operations.<o:p></o:p></p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-87478506418254710522023-02-23T21:59:00.001-08:002023-02-23T21:59:38.312-08:00What is the cost of iso 9001 certification?<p> </p><p class="MsoNormal">The <a href="https://www.iso-certification.us/iso-9001-certification-cost.html" target="_blank">cost of ISO 9001 certification</a> can vary depending on
several factors, including the organization’s size, the complexity of its
operations, the number of locations, and the certification body chosen.<o:p></o:p></p>
<p class="MsoNormal">Here are some of the main costs to consider:<o:p></o:p></p>
<p class="MsoNormal">1.<span style="mso-tab-count: 1;"> </span>Certification
body fees: The certification body conducts the audit and issues the
certification, and their fees can vary widely depending on the scope of the
audit, the size of the organization, and the level of complexity of the QMS. <o:p></o:p></p>
<p class="MsoNormal">2.<span style="mso-tab-count: 1;"> </span>Consultancy
fees: Many organizations work with a consultant to help implement the ISO 9001 standard and prepare for the audit. The consultancy fees
can vary depending on the level of support required and the duration of the
engagement.<o:p></o:p></p>
<p class="MsoNormal">3.<span style="mso-tab-count: 1;"> </span>Internal
costs: Implementing the ISO 9001 standard can include
staff training, documentation, and process improvements.<o:p></o:p></p>
<p class="MsoNormal">It is important to note that while ISO 9001 certification
can be a significant investment, it can also provide many benefits to the
organization, such as improved quality, increased customer satisfaction, and competitive
advantage. The cost of certification is a long-term investment
in the organization's success.<o:p></o:p></p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-2830260413845375982023-02-23T21:54:00.001-08:002023-02-23T21:54:27.544-08:00Steps in ISO 9001 certification<p> </p><p class="MsoNormal">ISO 9001 is a globally recognized standard for quality
management systems that help organizations to enhance customer satisfaction and
continual improvement. The certification process for ISO 9001 involves several
steps, which are outlined below:<o:p></o:p></p>
<p class="MsoNormal">1.<span style="mso-tab-count: 1;"> </span>Gap
analysis: This is the initial step in the certification process, where an
organization assesses its current quality management system against the
requirements of the ISO 9001 standard. It involves identifying any gaps or
areas of improvement needed to meet the standard's requirements.<o:p></o:p></p>
<p class="MsoNormal">2.<span style="mso-tab-count: 1;"> </span>Documentation:
After identifying the gaps, the organization must develop a <a href="https://www.iso-certification.us/quality-manual.html" target="_blank">Quality Manual</a> and
associated procedures and documents to meet the ISO 9001 requirements. The
documentation will include the organization's policies, procedures, and
instructions.<o:p></o:p></p>
<p class="MsoNormal">3.<span style="mso-tab-count: 1;"> </span>Implementation:
The organization will implement the Quality Management System (QMS) by implementing
documented policies, procedures, and instructions.<o:p></o:p></p>
<p class="MsoNormal">4.<span style="mso-tab-count: 1;"> </span>Internal
Audit: The organization will perform an <a href="https://www.iso-certification.us/Internal-audit.html" target="_blank">internal audit</a> to verify the QMS's
effectiveness and compliance with the ISO 9001 standard. This audit will check
whether the organization has implemented the QMS according to the documented
procedures and whether the QMS is effective in meeting the standard's
requirements.<o:p></o:p></p>
<p class="MsoNormal">5.<span style="mso-tab-count: 1;"> </span>Management
Review: The organization's top management will review the QMS's performance and
effectiveness based on the internal audit findings and identify areas for
improvement.<o:p></o:p></p>
<p class="MsoNormal">6.<span style="mso-tab-count: 1;"> </span>Certification
Audit: An external certification body will independently audit the
organization's QMS to verify compliance with the ISO 9001 standard. This audit
will be carried out in two stages: a document review to assess the
organization's readiness for the certification audit and a site audit to verify
the QMS's compliance.<o:p></o:p></p>
<p class="MsoNormal">7.<span style="mso-tab-count: 1;"> </span>Certification:
After successfully completing the certification audit, the organization will
receive an <a href="https://www.iso-certification.us/iso-9001-certificate.html">ISO 9001 certificate</a> valid for three years, subject to surveillance
audits to maintain certification.<o:p></o:p></p>
<p class="MsoNormal">Overall, achieving <a href="https://www.iso-certification.us/" target="_blank">ISO 9001 certification</a> requires a
comprehensive and ongoing commitment to quality management practices to provide
customer satisfaction and continuous improvement.<o:p></o:p></p>FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-19389716777146311422020-06-14T09:29:00.001-07:002020-06-14T09:30:29.368-07:00FDA Import Requirements for Hand Sanitizer<div dir="ltr" style="text-align: left;" trbidi="on">
<a href="https://www.fdahelp.us/hand-sanitizer-import-requirements-fda.html" target="_blank">FDA import requirements for hand sanitizer</a> are<br />
<br />
for manufacturer<br />
<br />
<br />
<ul style="text-align: left;">
<li>FDA registration</li>
<li>NDC number</li>
<li>Drug listing</li>
</ul>
<br />
<br />
for private label distributor<br />
<br />
<br />
<ul style="text-align: left;">
<li>NDC number</li>
<li>Drug listing</li>
</ul>
<br />
<br />
for Drug importer<br />
<br />
<br />
<ul style="text-align: left;">
<li>No registration or listing obligations</li>
</ul>
<div>
<a href="https://www.fdahelp.us/otc-drug-registration-process-fda.html" target="_blank">FDA registration Process for Hand sanitizer</a></div>
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-13835397942013043962019-04-11T14:59:00.001-07:002020-06-14T09:22:16.818-07:00FDA Approved Hand Sanitizer final rule<div dir="ltr" style="text-align: left;" trbidi="on">
FDA approved final rule on antiseptic <a href="https://www.fdahelp.us/fda-registration-hand-sanitiszer.html" target="_blank">hand-sanitizer</a>. FDA made 28 active ingredients in OTC Monograph as ineligible </div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com2tag:blogger.com,1999:blog-4648155843688951849.post-75593680623637760872017-02-28T21:07:00.001-08:002017-02-28T21:07:09.711-08:00FDA Registration and Other requirements<div dir="ltr" style="text-align: left;" trbidi="on">
<a href="https://fdahelp.us/fda-registration-number-search.html" target="_blank">FDA registration</a> requirements for <a href="https://fdahelp.us/fda-registration.html" target="_blank">food</a>, drug, medical device and cosmetics<br />
<br />
https://fdahelp.us/fda-registration.html </div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com4tag:blogger.com,1999:blog-4648155843688951849.post-33475084200267142822017-02-23T22:31:00.000-08:002017-02-28T21:08:41.545-08:00How do I get an ISO 9001 - 2015 Certificate?<div dir="ltr" style="text-align: left;" trbidi="on">
<a href="https://www.iso-certification.us/iso-9001-certificate.html" target="_blank">steps in ISO 9001 Certification</a><br />
<br /></div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-56179608667798645242015-08-26T11:19:00.000-07:002016-03-26T09:04:34.893-07:00Compounding Pharmacy Registration<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "times" , "times new roman" , serif; font-size: xx-small; line-height: 107%;"><span style="line-height: normal; text-align: left;">Written by, Regulatory specialist, LMG, Published on 8-26-2015</span></span><br />
<span style="font-size: 14.0pt; line-height: 107%;"><span style="font-size: small; line-height: normal; text-align: left;"><br /></span></span>
<span style="font-size: 14.0pt; line-height: 107%;">Compounding
is a preparation in which a licensed pharmacist or physician, or, in the case
of an outsourcing facility, a person under the guidance of a licensed
pharmacist, combines, mixes, or alters ingredients of a drug to create a
medication custom-made to the needs of an individual patient.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-size: 14.0pt; line-height: 107%;">Compounded
drugs are not FDA-approved, FDA does not verify the safety, or</span>
<span style="font-size: 14.0pt; line-height: 107%;">efficiency of compounded drugs. </span><span style="font-size: 14pt; line-height: 107%;">State boards
of pharmacy will continue to have major responsibility for the day-to-day
oversight of state-licensed pharmacies that <a href="http://www.fdahelp.us/compounding_pharmacy_fda_registration.html" target="_blank">compound drugs</a> in agreement with
the conditions of section 503A of the FDCA, although FDA retains some influence
over their operations. But, outsourcing facilities that register under section
503B are regulated by FDA and must fulfil the CGMP requirements and will be
inspected by FDA according to a risk-based schedule.</span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-size: 14pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-size: 14.0pt; line-height: 107%;">An
“outsourcing facility” is the place where they compound the sterile drugs.</span><span style="font-size: 14pt; line-height: 107%;">An
outsourcing facility can qualify for exceptions from the FDA approval
requirements and the condition to label products with adequate directions for
use, but not the exclusion from current good manufacturing practice (CGMP)
requirements. </span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-size: 14pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-size: 14pt; line-height: 107%;">Outsourcing facilities:</span></div>
<div class="MsoNormal" style="text-align: left;">
<span style="font-size: 18.6666660308838px; line-height: 19.9733333587647px;"><br /></span><span style="font-family: "symbol"; font-size: 14pt; line-height: 107%; text-indent: -0.25in;">·<span style="font-family: "times new roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="font-size: 14pt; line-height: 107%; text-indent: -0.25in;">Must comply with <a href="http://www.fdahelp.us/21_CFR_820.html" target="_blank">CGMP requirements</a>;</span><br />
<span style="font-family: "symbol"; font-size: 14pt; line-height: 107%; text-indent: -0.25in;">·<span style="font-family: "times new roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="font-size: 14pt; line-height: 107%; text-indent: -0.25in;">Will be inspected by FDA according to
a risk-based schedule</span><br />
<span style="font-family: "symbol"; font-size: 14pt; line-height: 107%; text-indent: -0.25in;">·<span style="font-family: "times new roman"; font-size: 7pt; font-stretch: normal; line-height: normal;"> </span></span><span style="font-size: 14pt; line-height: 107%; text-indent: -0.25in;">Must meet certain other conditions,
such as reporting adverse events and providing FDA with certain information
about the products they compound.</span></div>
<div class="MsoNormal" style="text-align: left;">
<span style="font-size: 14pt; line-height: 107%; text-indent: -0.25in;"><br /></span></div>
<div class="MsoNormal" style="text-align: left; text-indent: -24px;">
<a href="http://www.fdahelp.us/compounding_pharmacy_fda_registration.html" target="_blank"> <b> Outsourcing Facility registration with FDA</b></a></div>
<div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
<span style="font-size: 14.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;">Outsourcing
facility can register with FDA using electronic drug registration system.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;">If the
facilities engages compounding sterile human drugs they may <a href="http://www.fdahelp.us/" target="_blank">register withFDA</a> as an Outsourcing facility.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;">If the
facility engages in repacking human drugs, mixing, diluting or repacking
biological products, compounding non-sterile drugs and compounding animal drugs
do not need to register as an outsourcing facility since the drugs it produce
will not be eligible for the exemptions as in 503B of FD&C Act.<o:p></o:p></span><br />
<div style="text-align: left;">
<span style="line-height: 107%;"><br /></span></div>
<div style="text-align: left;">
<h4 style="text-align: left;">
<span style="font-size: x-small;"><a href="http://www.fdahelp.us/" target="_blank">Liberty Management Group LTD</a>, one of the leading FDA consulting group in the USA, can assist you with register your facility with FDA, LMG will help you with SPL preparation and submission to FDA, Drug establishment registration, drug listing and provide US Agent service to foreign facilities.</span></h4>
</div>
<span style="font-size: 14.0pt; line-height: 107%;"></span><br />
<br /></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-size: 14.0pt; line-height: 107%;"><br /></span></div>
<a href="http://www.fdahelp.us/compounding_pharmacy_fda_registration.html" style="font-size: 14pt; line-height: 107%;" target="_blank">OutsourcingFacility Fees for Fiscal Year 2016</a><br />
<br />
<br />
<br />
<br /></div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com1United States39.549241263198567 -100.898437514.027206763198567 -142.2070315 65.071275763198571 -59.5898435tag:blogger.com,1999:blog-4648155843688951849.post-87227906607631091012015-06-16T13:11:00.000-07:002016-03-26T09:24:46.385-07:00FDA Regulations for API<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: left;">
<span style="font-family: Times, Times New Roman, serif; font-size: xx-small;">written by: FDA regulatory specialist </span><span style="font-family: Times, 'Times New Roman', serif; font-size: xx-small;">Published on 6-6-2015</span></div>
<h2 style="text-align: left;">
<span style="font-family: inherit; font-size: x-small;">What is API</span></h2>
<h1>
<span style="font-family: inherit; font-size: x-small;"><o:p></o:p></span></h1>
<div class="MsoNormal" style="margin-left: 50.25pt;">
<span style="font-family: inherit; font-size: x-small;"><a href="http://www.fdahelp.us//api-listing.html" target="_blank"><b>A</b>ctive <b>P</b>harmaceutical <b>I</b>ngredient</a> is a product which is not
intended to consume directly by human.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: 50.25pt;">
<span style="font-family: inherit; font-size: x-small;"><a href="http://www.fdahelp.us//otc-drug-products.html" target="_blank">Drugs</a> which does not have enough
information on the label regarding how to consume is also considered as API.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: 50.25pt;">
<span style="font-family: inherit; font-size: x-small;">API are involved in the
manufacturing of finished drugs.<o:p></o:p></span></div>
<h2 style="text-align: left;">
<span style="font-family: inherit; font-size: x-small;">Regulations for API with FDA</span></h2>
<h1>
<span style="font-family: inherit; font-size: x-small;"><o:p></o:p></span></h1>
<div class="MsoNormal" style="margin-left: 50.25pt;">
<span style="font-family: inherit; font-size: x-small;">All domestic and foreign API
Manufacturers have to <a href="http://www.fdahelp.us//fda-drug-registration.html" target="_blank">register</a> their facility or establishment with FDA.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: 49.5pt;">
<span style="font-family: inherit; font-size: x-small;">All API should possess a <a href="http://www.fdahelp.us//fda-labeler-code.html" target="_blank">NDC number</a>
which is unique for each API.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: 49.5pt;">
<span style="font-family: inherit; font-size: x-small;">All API imported inside US must
be listed with FDA.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: 49.5pt;">
<span style="font-family: inherit; font-size: x-small;">Self-Identification is required
for all domestic and foreign facility where API for generic drug is manufactured.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-left: 49.5pt;">
<span style="font-family: inherit; font-size: x-small;">All foreign API manufacturers
should have an U.S.Agent.<o:p></o:p></span></div>
<div class="MsoTitle">
<br /></div>
<h2 style="text-align: left;">
<span style="font-family: inherit; font-size: x-small;"> Services provided by LMG for API
manufacturers.</span></h2>
<h1>
<span style="font-family: inherit; font-size: x-small;"><o:p></o:p></span></h1>
<div class="MsoNormal" style="margin-left: .25in;">
<span style="font-family: inherit; font-size: x-small;"><a href="http://www.fdahelp.us//index.html" target="_blank">LMG </a>assists API manufacturer to
electronically submit Self-identification, facility registration, NDC labeler
code and drug listing.<o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="margin-left: .25in;">
<span style="font-family: inherit; font-size: x-small;">LMG provides US Agent service for
foreign API manufacturers.</span><o:p></o:p></div>
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com1tag:blogger.com,1999:blog-4648155843688951849.post-36227625366312479862015-06-16T12:59:00.000-07:002016-03-26T09:29:56.843-07:00FDA CERTIFICATE OF FREE SALE<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="text-align: justify;">
Certificate of Free sale, which is also known as <a href="http://www.fdahelp.us/fda_registration/fda-export-certificate.html" target="_blank">FDA Export Certificate</a> is a document which certifies that the product manufactured in US is eligible for export. This certificate states that there are no overheads or pending impulsive actions on the manufacturer. This is a document which contains information about a product’s regulatory and marketing status.</div>
<div style="text-align: justify;">
This Certificate of free sale or export certificate is needed by many foreign governments because they want to ensure that the products marketed in their country comply with <a href="http://www.fdahelp.us//index.html" target="_blank">US FDA regulations</a>. This is issued by the FDA upon request by the manufacturer which meet the FDA regulations. </div>
<div style="text-align: justify;">
The certificate of free sale is for food including dietary supplements and cosmetics. FDA export certificate is for human drugs, animal drugs and medical devices that meet up with the FDA standards and the manufacturers should follow the <a href="http://www.fdahelp.us//21_CFR_820.html" target="_blank">cGMP</a>.</div>
<div style="text-align: justify;">
FDA will not issue the Certificate of free sale or export certificate, if the product is not exported from US. Manufacturers has to register their facility with FDA before they apply for the Certificate of free sale from FDA.</div>
<div>
<br />
Liberty Management Group Ltd, US based leading FDA Consulting group can guide you through the export certificate request process, which will help you to get the process easier. <a href="http://www.fdahelp.us/" target="_blank">LMG</a> also provide assistance with facility registration with FDA.<br />
<br />
written by : FDA Registration Specialist, LMG<br />
Published on : 6-16-2015</div>
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com1tag:blogger.com,1999:blog-4648155843688951849.post-23286599114138784722014-10-09T20:43:00.000-07:002014-10-09T20:43:47.548-07:00FDA Biennial Registration Renewal 2014<div dir="ltr" style="text-align: left;" trbidi="on">
All food facilities registered with FDA should complete their <a href="http://www.fdahelp.us/index.html">biennial renewal</a> before December 31st 2014</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com1tag:blogger.com,1999:blog-4648155843688951849.post-86618488839868064522014-08-01T12:08:00.000-07:002014-08-02T09:04:11.856-07:00FDA Announces Medical Device User fee for FY 2015<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<b><span lang="EN" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: EN;"> </span></b></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span lang="EN" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: EN; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;">The annual <a href="http://www.fdahelp.us/medicaldevices.html">establishment registration</a> fee must be paid between October
1, 2014 and December 31, 2014. For FY15, the registration<a href="http://www.fdahelp.us/fda_registration/fees.html"> fee</a> for each
establishment is $3,646 </span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<b><span lang="EN" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: EN;"><br /></span></b></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<b><span lang="EN" style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-ansi-language: EN;"> FY15 User Fees (in
U.S. Dollars)<o:p></o:p></span></b></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<br /></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; border: none; margin-left: 6.15pt; mso-border-alt: dashed windowtext .75pt; mso-padding-alt: 0in .5pt 0in .5pt; mso-table-layout-alt: fixed;">
<tbody>
<tr>
<td style="border: solid windowtext 1.5pt; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">application
type</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.5pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: solid windowtext 1.5pt; padding: 0in .5pt 0in .5pt; width: 1.3in;" valign="top" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">standard
fee</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><o:p></o:p></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.5pt; padding: 0in .5pt 0in .5pt; width: 1.75in;" valign="top" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">small
business fee</span></b></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">510(k)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" valign="top" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$5,018<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$2,509<o:p></o:p></span></div>
</td>
</tr>
<tr style="height: 16.15pt; mso-yfti-irow: 2;">
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; height: 16.15pt; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">513(g)<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 16.15pt; padding: 0in .5pt 0in .5pt; width: 1.3in;" valign="top" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$3,387<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; height: 16.15pt; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$1,694<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">PMA,
PDP, PMR, BLA<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" valign="top" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$250,895<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" valign="top" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$62,724<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">panel-track
supplement<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$188,171<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$47,043<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">180-day
supplement<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$37,634<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$9,409<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">real-time
supplement<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$17,563<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$4,391<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">BLA
efficacy supplement<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" valign="top" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$250,895<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$62,724<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-bottom: solid windowtext 1.0pt; border-left: solid windowtext 1.5pt; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">annual
report<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$8,781<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$2,195<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border-top: none; border: solid windowtext 1.5pt; padding: 0in .5pt 0in .5pt; width: 149.4pt;" valign="top" width="249"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 7.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">30-day
notice<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.5pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.3in;" width="156"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 15.7pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$4,014<o:p></o:p></span></div>
</td>
<td style="border-bottom: solid windowtext 1.5pt; border-left: none; border-right: solid windowtext 1.5pt; border-top: none; padding: 0in .5pt 0in .5pt; width: 1.75in;" width="210"><div class="MsoNormal" style="margin: 0in 0in 0.0001pt 16.6pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">$2,007<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
<br />
<div class="MsoNormal" style="line-height: 115%; margin-bottom: 10.0pt; mso-layout-grid-align: none; mso-pagination: none; text-autospace: none;">
<br /></div>
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-83585915836778259032013-10-10T14:21:00.000-07:002013-10-10T14:21:36.243-07:00FDA Activities are limited due to government shutdown<div dir="ltr" style="text-align: left;" trbidi="on">
<div>
<br /></div>
FDA activities are limited from October 1, 2013, and continuing until the date of enactment of FY 2014 appropriation.<div>
<br /><div>
<a href="http://www.fdahelp.us/otc-drug-products.html">Drug Registration</a><br /><br />Even though the activities are limited FDA is accepting SPL submission for Drug establishment registration, <a href="http://www.fdahelp.us/otc-drug-products.html">Drug listing</a> and <a href="http://www.fdahelp.us/ndc-labeler-code.html">NDC Labeler code request</a>. But the <a href="http://www.fdahelp.us/fda-labeler-code.html">NDC Labeler code assignment</a> may be delayed.</div>
<div>
<br /></div>
<div>
<a href="http://www.fdahelp.us/fda-food-registration.html">Food Facility Registration</a>.<br /><br />The food facility registration and prior notice modules are working fine during the lapse period<br /></div>
<div>
<br /></div>
<div>
<a href="http://www.fdahelp.us/medicaldevices.html">Medical Device Registration</a><br /><br />FDA is not collecting the Establishment registration fee for the year 2014, which may affect the registration and listing of new medical device and renewal of existing registrations.<br /><br /><div>
FDA is not accepting 2014 medical device user fees for regulatory submissions like 510 (k) for 2014 fiscal year which may affect the new submission to FDA.<br /><div class="MsoNormal">
<br /></div>
</div>
</div>
</div>
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-54462138098753624642013-01-25T09:34:00.003-08:002013-01-25T09:36:10.428-08:00FDA Biennial Registration Renewal<div dir="ltr" style="text-align: left;" trbidi="on">
The extended time for <a href="http://www.fdahelp.us/Reg_food.html">FDA Biennial Registration Renewal</a> will end by Jan 31, 2013. After that FDA may suspend the registration.<br />
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-86891681510964063582012-12-04T13:56:00.000-08:002012-12-04T13:56:56.570-08:00FDA announce Two-Week Grace Period for Generic Drug Facility Identification<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<div class="MsoNormal">
FDA announced a two-week grace period, until December 18,
2012, for Generic Drug Facilities that have not yet successfully completed the
self-identification process.</div>
<div class="MsoNormal">
The FY 2013 reporting period for facility
self-identification closed on December 3, 2012.
Under the statute, generic drug products manufactured in facilities that
have not self-identified, or including active ingredients manufactured in
facilities that have not self-identified, are misbranded. </div>
<div class="MsoNormal">
source: fda</div>
</div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-11679641051611810012012-10-09T19:29:00.000-07:002012-10-09T19:29:09.494-07:00US FDA against illegal online pharmacies<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: Arial, sans-serif; font-size: 11.818181991577148px;">The U.S. FDA took action against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.</span><br />
<a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm322492.htm">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm322492.htm</a></div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0tag:blogger.com,1999:blog-4648155843688951849.post-2211242731371069952012-08-21T11:08:00.000-07:002012-08-21T11:12:44.654-07:00New FDA Medical Device Establishment Registration Requirements<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="font-family: Verdana, sans-serif;">FDA published the new requirements for Medical Device Establishments. As per the new requirements All medical device establishments - both domestic and foreign - needs to pay FDA registration fee regardless of activities conducted in the facility. the new fee for the year 2013 which starts from October 1st will be <b>USD 2575.</b></span></div>
FDA BLOGhttp://www.blogger.com/profile/14799247128579397856noreply@blogger.com0