FDA Threatens Import Refusal for Chinese Pharmaceutical Facility
The Food and Drug Administration may refuse imports of pharmaceuticals manufactured at a Chinese facility because of violations of current good manufacturing practice requirements, it said in a warning letter dated Dec. 19 (here). The agency said its inspectors found…
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the violations in manufacturing procedures for finished pharmaceuticals and active pharmaceutical ingredients during a tour of Novacyl Wuxi Pharmaceutical Co., Ltd.’s facility in Wuxi, China. Unless they are corrected, FDA may place products from the facility on import alert and detention without physical examination, it said.