FDA May Refuse Imports of Chinese Drug Co. w/ Lapsed Registration
In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews…
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its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.