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.
The Food and Drug Administration issued its weekly Enforcement Report for July 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 July 17 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 said the Office of Management and Budget approved its survey of "Health Care Providers' Responses to Medical Device Labeling." The FDA submitted the proposed information collection to OMB March 8, it said. The approval expires July 31, 2015. A copy of the supporting statement for this information collection is at http://www.reginfo.gov/public/do/PRAMain. Further information: Daniel Gittleson, 301-796-5156 or Daniel.Gittleson@fda.hhs.gov.
On July 16 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 July 9-16, 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 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: