FDA Threatens 2 Device Makers, 1 Fish Processor for Violations of CGMP & HACCP
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…
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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.