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:
The Food and Drug Administration is seeking nominations for a nonvoting industry representative(s) on the Pediatric Advisory Committee to the Office of the Commissioner. Nominations are due by Sept. 10. Organizations interested in assisting FDA in selecting the committee members should also notify FDA by Sept. 10.
The Food and Drug Administration issued its weekly Enforcement Report for Aug. 8 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
Chinese drug manufacturer Jiangsu Province Jianerkang Medical Dressing will remain on import alert, and approval of new applications or supplements withheld, until it implements a robust quality system to comply with current good manufacturing practices (CGMP), said the Food and Drug Administration in a warning letter sent July 30. A Sept. 2011 inspection had found numerous violations of CGMP including, among other things, bacteria on antiseptic wipes manufactured by Jainerkang intended for use on wounds. The firm’s Oct. 2011 response to the inspection lacked sufficient corrective actions, FDA said.
On Aug. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 6 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, in cosponsorship with Parenteral Drug Association (PDA), announced a public conference Sept.10-12 in Baltimore on "Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture." The conference will cover issues affecting the industry and explore strategies and approaches for ensuring conformance with regulations to facilitate the development and continuous improvement of safe and effective medical products, FDA said.
During the week of July 30 - Aug. 5, 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 Aug. 3 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 warning letters to two medical device manufacturers in Germany and China, respectively, as well as a fish and fishery product processor in the Philippines, threatening detention without physical examination and/or refusal of future device applications. Ningbo Huahui Medical Instruments Company Limited (here), of China, and Leisegang Feinmechanik-Optik GmbH (here), of Germany, were cited for violations of current good manufacturing processes in their medical device manufacturing. Huahui was threatened with detention without physical examination if the violations are not corrected, and the FDA told Leisengang that its premarket license applications for Class III devices would not be approved. The FDA also told Philippine fish processor Well -- Delight Network Corporation (here) that its products may be detained unless it revises its Hazard Analysis & Critical Control Points (HACCP) plan.