FDA announce Two-Week Grace Period for Generic Drug Facility Identification

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.

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. 

source: fda

US FDA against illegal online pharmacies

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.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm322492.htm

New FDA Medical Device Establishment Registration Requirements

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 USD 2575.

FDA Food registration FAQ

Frequently asked questions and answers about FDA food registration
http://www.fdaregistration-us.com/fda_registration/fda-registration-food.html

Cosmetics contain mercury

FDA warns consumers against using cosmetics contains mercury. Exposure to mercury can have serious health consequences.
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM294876.pdf
http://www.fdaregistration-us.com/vcrp.html 

Toothbrush Can Chip Teeth and Cause Choking

When using your electric toothbrush, you don’t expect parts of the device to pop off and chip your tooth, fly into your eyes or get stuck in your throat.

But that’s exactly what has happened to some users of the battery-powered Arm & Hammer Spinbrush—or the Crest Spinbrush, as it was called before 2009.

 read more  http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM291863.pdf

FDA Detention- Food, Medical Device, Cosmetics and Drugs

Most of the products detained by FDA are due to non-compliance with FDA requirements. Liberty Management Group Ltd. assists exporters and importers to release the detained product by brought the product in to compliance with the FDA regulations

http://www.fdaregistration-us.com/fda_registration/fda-detention.html

FDA Testing Orange Juice Imports for Carbendazim

Fungicides are chemical compounds or biological organisms used to kill or inhibit fungi or fungal spores that can cause serious damage in agriculture. Carbendazim is approved for use in a variety of crops, including citrus, in many countries. In the United States, however, the Environmental Protection Agency (EPA) has not approved carbendazim for use as a fungicide on oranges, nor has it established a tolerance or an exemption from the need for a tolerance for carbendazim in orange juice in the United States.  Thus, carbendazim in orange juice is an unlawful pesticide chemical residue under the Federal Food, Drug, and Cosmetic Act
   FDA is  sampling import shipments of orange juice and will deny entry to shipments that test positive for carbendazim

read more....  http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm286302.htm

FDA Alerts - Similar-Sounding Drugs Durezol and Durasal

FDA is alerting  of potential injury due to confusion between the FDA-approved eye medicine Durezol (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover Durasal (salicylic acid) 26%.

http://www.fda.gov/Drugs/DrugSafety/ucm285235.htm

FDA Registration and US Agent Representation Fees

Liberty Management Group Ltd. Announce its fees for FDA registration and US Agent service.
http://www.fdaregistration-us.com/fda_registration/fees.html