FDA to Continue to Refuse Entry for Chinese API Manufacturer
The Food and Drug Administration may continue to refuse imports of active pharmaceutical ingredients from a Chinese drug conglomerate after an inspection by agency officials detailed violations of current good manufacturing practice requirements, it said in a warning letter dated…
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July 9. FDA said until the violation are corrected, it may keep APIs made by Zhejiang Jiuzhou Pharmaceutical or exported by its trading company Zhejiang Zonebanner Jiuzhou Imp. & Exp. on import alert.