FDA WARNING_LETTER - Shijiazhuang Pharma. Group Zhongnuo Pharmaceuticals Co. Ltd

This FDA Warning Letter (WL: 300-12-013), dated June 14, 2012, addresses Shijiazhuang Pharma. Group Zhongnuo Pharmaceuticals Co. Ltd. regarding violations of the Federal Food, Drug, and Cosmetic Act. The FDA's review of drug shipments and registration records revealed the company failed to register its establishment for 2011 or 2012, despite continuing to manufacture and import drugs into the U.S.

This failure to register is a prohibited act under section 301(p) of the Act (21 U.S.C. § 331(p)) and violates section 510(i)(1) (21 U.S.C. § 360(i)(1)), which requires annual electronic registration for foreign establishments. Additionally, drugs cannot be imported unless listed per 21 CFR part 207, subpart C, and manufactured at a registered establishment (21 CFR § 207.40(b)). Unregistered drugs may be refused admission under section 801(o) or 801(a)(3) as adulterated or misbranded. Failure to list drugs or update listing information, including the manufacturing establishment's registration number (21 CFR § 207.25(b)(7)), renders drugs misbranded under section