FDA WARNING_LETTER - Zhejiang Xianju Chemical Pharmaceutical Factory

The FDA issued a Warning Letter to Zhejiang Xianju Chemical Pharmaceutical Factory on January 25, 2012, for failing to fulfill drug establishment registration obligations. The FDA's review indicated the factory had not registered its establishment in 2011 or 2012, despite continuing to manufacture and import drugs into the United States.

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 drugs may be refused admission under Section 801(o) or 801(a)(3) if appearing adulterated or misbranded. Failure to list drugs as required by Section 510(j) or provide information renders a drug misbranded under Section 502(o).

The FDA previously notified the factory on October 11, 2011, about its unregistered status