On Oct. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 21-28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 25 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 is refusing imports of wheelchairs and standing frames from Danish device company R82 A/S for violations of current good manufacturing practice requirements, according to a warning letter dated Oct. 18. The letter said entry will be refused for the following R82 products, “given the serious nature of the violations”: the Cougar wheelchair, the Panther wheelchair, the Cheetah wheelchair, the Flamingo wheelchair, the Stingray mechanical chair, the Tiger 2000 mechanical chair, the Serval mechanical chair, the Wombat chair, the Nandu chair, the Swan bath chair, the Manatee bath chair, the Rabbit mobile standing frame, the Buffalo standing frame, the Gazelle standing frame, and the Toucan standing frame. The import alert won’t be lifted until the violations are corrected, FDA said.
The Food and Drug Administration posted more information on its proposed food safety rules for animal feed and pet food, in conjunction with its release of the proposed rule Oct. 25 (see 13102519). The webpage includes an overview of the rules, a fact sheet, and a questions and answers document. It also has a table on exemptions and modified requirements for both preventative controls and CGMP requirements for animal food. FDA said it will publish within six months of its final animal food rule a guidance document that explains the new regulations in plain language to help businesses comply with the rule.
On Oct. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 23 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 Oct. 23 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. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: