The Food and Drug Administration is asking for comments on possible changes to its regulation requiring animal drug sponsors to submit reports, including periodic drug experience reports containing drug distribution data showing the amount of the drug distributed domestically and the amount exported. Specifically, FDA is seeking comments on: (1) whether it should require the submission of additional sales and distribution information including an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each approved food-producing animal species; (2) how to compile and present its annual summary report of the sales and distribution data collected from sponsors of antimicrobial new animal drugs; and (3) alternative methods available to FDA for obtaining additional data and information about the extent of antimicrobial drug use in food producing animals. Comments are due by Sept. 25.
On July 24 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 July 25 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 posted warning letters that it has sent to companies from Taiwan, Indonesia, and France, threatening detention without physical examination and/or suspension and revocation of licenses. Indonesian device manufacturer Gooten Innolife Corp. (here) was told that some of its products will remain on detention without physical examination until violations of current good manufacturing practices (CGMPs) are corrected, and French drug manufacturer Sanofi Pasteur (here) and (here) was threatened with license suspension and/or revocation for the same reason. The FDA told Indonesian fish processor P.T. Super Saku Bali (here) that its products may be refused entry through detention without physical determination if it doesn’t submit a revised Hazard Analysis and Critical Control Point (HACCP) plan.
During the week of July 16-22, 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 of:
On July 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 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 posted five warning letters sent in May and June to companies in China, Italy, and Mexico, in which it threatened to place or maintain these companies’ products on detention without physical examination, and/or refuse premarket approval applications for Class III devices from these companies. The five companies include device manufacturers Foshan R. Poon Medical Products Co. , Ltd (China) (here); Dongguan Yongrong Plastic Products Co., Ltd. (China) (here), Guangdong Baihe Medical Technology Co., Ltd. (China) (here); and RI. MOS. S.R.L. (Italy) (here). The FDA also sent a warning letter to drug manufacturer Compañía Internacional de Comercio, S.A. de C.V. (Mexico) (here) in which it said its drugs would remain on import alert subject to refusal at the border until the company takes corrective action. The FDA had conducted inspections at these companies’ facilities and found their products to be adulterated.
Gills Onions, LLC of Oxnard, Calif., is initiating a voluntary recall of a single day’s production of diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes, said the Food and Drug Administration. The recalled products, which are packaged under the brand "Gill's Onions," were shipped between July 2-4, 2012 directly from Gills Onions to retailers in Canada and the following U.S. states: California, Montana, Oklahoma, Oregon, Pennsylvania, Texas, Utah and Washington. The voluntary recall was initiated when the company was notified by FDA that a random sample of diced yellow onions taken at retail tested positive for Listeria monocytogenes. As a precautionary measure, Gills Onions is recalling all products processed on the same day and on the same line as the sample that tested positive, FDA said.