FDA WARNING_LETTER - Changzhou Qianhong Bio-Pharma Co., Ltd - July 09, 2013

The FDA issued a Warning Letter to Changzhou Qianhong Bio-Pharma Co., Ltd on June 4, 2013, following a review of drug shipments into the U.S. and the company's drug registration and listing information. The review revealed the company failed to fulfill its registration obligations under the Federal Food, Drug, and Cosmetic Act (the Act).

Specifically, the company manufactured, prepared, propagated, compounded, or processed drugs imported or offered for import into the U.S. while not registered. This violates Section 510(i)(1) of the Act, which requires annual electronic registration for foreign establishments engaged in drug manufacturing for U.S. import. Failure to register is a prohibited act under Section 301(p) of the Act. Additionally, drugs from unregistered establishments may be refused admission under Section 801(a)(3) and are considered misbranded under Section 502(o) of the Act.

To remedy these violations, Changzhou Qianhong Bio-Pharma Co., Ltd must immediately register its establishment and properly list drugs offered for import. The company must notify the FDA in writing within fifteen working days of receipt of the letter, detailing corrective actions. If unable to complete actions within this timeframe, a reason for delay and a new completion date must be provided. If the company ceases U.S. drug imports, it must notify the FDA and provide discontinuance notice per Section