FDA WARNING_LETTER - Zhucheng Haotian Pharm Co., Ltd.

This FDA Warning Letter, dated June 11, 2012, was issued to Zhucheng Haotian Pharm Co., Ltd. for failing to fulfill drug establishment registration and listing obligations. The FDA's review of drug shipments into the U.S. and the company's registration records revealed that the establishment had not registered in 2011 or 2012, despite continuing to manufacture and import drugs into the U.S. The FDA had previously notified the company of this issue on October 11, 2011.

This failure to register annually is a prohibited act under Section 301(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 331(p)], violating Section 510(i)(1) [21 U.S.C. § 360(i)(1)]. Additionally, drugs cannot be imported unless listed per 21 CFR Part 207, Subpart C, and manufactured at a registered foreign establishment [21 CFR § 207.40(b)]. Failure to list a drug as required, or to provide necessary information, renders it misbranded under Section 502(o) [21 U.S.C. § 352(o)]. Since the establishment's registration lapsed, any drug listings associated with