FDA WARNING_LETTER - Quzhou Chemsyn Pharm Co Ltd

The FDA issued a Warning Letter to Quzhou Chemsyn Pharm Co., Ltd. on September 6, 2012, due to the company's failure to fulfill its drug establishment registration obligations. The FDA's review of drug shipments into the U.S. and the company's registration records revealed that Quzhou Chemsyn Pharm Co., Ltd. had not registered its establishment in 2011 or 2012, despite continuing to manufacture and import drugs into the U.S.

This failure violates Section 510(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360(i)(1)), which requires annual electronic registration for foreign establishments manufacturing drugs imported into the U.S. This is a prohibited act under Section 301(p) of the Act (21 U.S.C. § 331(p)). 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)). Unregistered establishments or unlisted drugs can lead to refusal of admission under Sections 801(o) and 801(a)(3) of the Act, and misbranding under Section 502(o) (21 U.S