The Food and Drug Administration issued its weekly Enforcement Report for Aug. 14 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 will hold a series of public meetings on its Foreign Supplier Verification Program and third-party accreditation body proposed rules, with the first to be held in Washington, D.C., on Sept. 19-20. The meetings will give the public a chance to present comments and ask FDA officials questions about the rules, said FDA’s Federal Register notice. Two other identical meetings will be held in other locations that have yet to be announced by the agency. Although onsite registration is available for the D.C. meeting, FDA encouraged preregistration by Sept. 10 (here). Requests to make oral presentations at the D.C. meeting are due by Aug. 29.
On Aug. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Aug. 6-12, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Aug. 9 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 the Interstate Certified Shellfish Shippers List (ICSSL) for August. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration is amending its regulations on color additives to allow use of spirulina extract in candy and chewing gum. Effective Sept. 13, the blue-green coloring made from the dried biomass of the cyanobacteria A. platensis will be allowed provided certain conditions are met, including that the color additive not have any microcystin toxin. FDA’s action is in response to a petition filed by Mars, Inc. Written objections and hearing requests are due by Sept. 12.
Federal and local law enforcement agencies arrested seven U.S. and Canadian citizens for importing and distributing allegedly misbranded and unapproved drugs, said the U.S. Attorney’s Office for the Eastern District of Virginia on Aug. 7. A judge issued arrest warrants for three others, and another person facing charges is already in a Canadian prison. According to the attorney’s office, the 11 residents of Virginia, Maryland, Pennsylvania, Michigan, Florida and Canada were associated with Gallant Pharma, a drug company based in Crystal City, Va.
On Aug. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: