FDA WARNING_LETTER - Changzhou Wujin Zhengping Shuangma Chemical Plant

This FDA Warning Letter (WL: 300-12-011) dated May 31, 2012, was issued to Changzhou Wujin Zhengping Shuangma Chemical Plant, China, for failing to fulfill drug establishment registration obligations. The FDA's review of drug shipments to the U.S. and the company's registration/listing information revealed that the establishment had not registered for 2011 or 2012, despite continuing to manufacture and import drugs into the U.S.

This 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. Failure to register is a prohibited act under Section 301(p) (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 drugs may be refused admission under Section 801(o) or 801(a)(3) as adulterated or misbranded. Failure to list drugs or provide required information under Section 510 renders a drug