The U.S. Food and Drug Administration (FDA) conducted an inspection of Hangzhou Badi Daily Use chemical company, drug manufacturing facility located at Huzhou City, Zhejiang Province from March 19 to 21, 2019.
The warning letter summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Warning letter includes points such as methods, facilities, or controls for manufacturing, processing, packing, or holding which are not in compliance to CGMP; depicting the modification of drug products from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
Specific CGMP violations were observed by the inspector including:
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