The Food and Drug Administration postponed re-registration for facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. The biennial re-registration, which was required by the Food Safety and Modernization Act, was set to begin Oct. 1 and run until Dec. 31. FDA postponed the re-registration because it is still working to finalize related guidance documents, an FDA spokeswoman said. FDA is considering extending the Dec. 31 deadline and will announce its decision in the near future, she said. Check FDA's website at access.fda.gov at a later date to be informed when re-registration becomes available.
The Food and Drug Administration issued its weekly Enforcement Report for Oct. 3 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Oct. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
In cooperation with law enforcement, customs, and regulatory authorities from 100 countries, the Food and Drug Administration took action against more than 4,100 Internet pharmacies selling unapproved drugs to consumers, it said. The overall effort resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide. FDA’s actions included civil and criminal charges, seizure of illegal products, and removal of offending websites, it said.
On Oct. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Sept. 26 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration updated its frequently asked questions on the Food Safety Modernization Act (FSMA) registration requirements, which require facilities that are required to register to re-register every two years, and provide for the suspension of facilities’ registration by the FDA. The re-registrations will begin in October -- December 2012. FDA has been able to suspend registration of facilities since July 3, 2011. New sections of the FAQ include: