Peking Medicine Manufactory – FDA Warning Letter

The FDA issued a Warning Letter to Peking Medicine Manufactory on April 5, 2012, due to the company's failure to fulfill its drug establishment registration and drug listing obligations under the Federal Food, Drug, and Cosmetic Act.

The FDA's review of drug shipments into the U.S. and the company's registration records indicated that Peking Medicine Manufactory had not registered its establishment for 2011 or 2012, despite continuing to manufacture and import drugs into the U.S. This violates Section 510(i)(1) of the Act, 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).

Additionally, drugs offered for import must be listed per 21 CFR Part 207, Subpart C, and manufactured at a registered foreign establishment (21 CFR § 207.40(b)). The failure to list a drug or provide required information renders it misbranded under Section 502(o). Since Peking Medicine Manufactory's registration lapsed, any drug listings associated with it are considered out of date, creating an appearance of misbranding.

The FDA previously notified the company on October 11, 2011, about its unregistered status. As a result of these violations, drugs from Peking Medicine Manufactory may be refused admission into the