On Sept. 19 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. 18 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Sept. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 16 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 September. 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 said it plans to update forms required by processors of Low-Acid Canned Foods. Old FDA Forms 2541a and 2541c will be replaced by four new forms that are specific to different industry manufacturing practices, FDA said. The changes will make It easier for processors to submit information on manufacturing processes to FDA, the agency said. The switch to the new forms won’t happen until FDA has had a chance to request and review comments. Until then, low-acid canned food manufacturers should continue to use the old forms, FDA said.
The Food and Drug Administration announced two more public meetings where the agency will discuss its proposed rules on the Foreign Supplier Verification Program (FSVP) and third-party auditors. FDA will use the meetings to get input from the public and respond to questions about the proposals. The agency already scheduled one meeting in Washington, D.C., Sept. 20-21 (see 13081513). The next meeting will be in Miami Oct. 10-11. After that, a third meeting will be held in Long Beach, Calif. Oct. 22-23, FDA said.
The Food and Drug Administration will refuse entry of a device manufactured by Ulrich GmbH after finding violations of FDA regulations during an inspection of the company’s Ulm facility, the agency said in a warning letter dated Aug. 15. FDA said Ulrich’s Pezo PEEK Cage System doesn’t conform to current good manufacturing practice and medical device reporting requirements. FDA detention without physical examination of the devices will continue until the violations are corrected, the agency said.
The Food and Drug Administration issued a new import alert Sept. 16 to block imports of drug products manufactured at Ranbaxy Laboratories’ facility in Mohali, India. FDA also extended the terms of a 2012 settlement that covered other Ranbaxy facilities in India to also cover the Mohali facility.