FDA Threatens Detention, Rejection of Applications for 5 Drug & Device Manufs.
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…
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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.