FDA WARNING_LETTER - Changzhou Jialing Medicine Industry Co Ltd

The FDA issued a Warning Letter to Changzhou Jialing Medicine Industry Co Ltd on December 29, 2011, due to the company's failure to fulfill drug establishment registration obligations under the Federal Food, Drug, and Cosmetic Act. The company continued to manufacture and import drugs into the U.S. in 2010 and 2011 without registering its establishment, despite being notified by the FDA on October 11, 2011.

This failure to register is a prohibited act under section 301(p) of the Act (21 U.S.C. § 331(p)). Additionally, drugs imported from an unregistered foreign establishment or not properly listed are subject to refusal of admission under sections 801(o) and 801(a)(3) of the Act, and may be deemed misbranded under section 502(o) for failure to list or update listing information.

The FDA requires Changzhou Jialing Medicine Industry Co Ltd to immediately register its establishment and properly list all drugs offered for import into the U.S. A written response detailing corrective actions must be submitted within fifteen working days of receiving the letter. If the company intends to cease importing drugs, it must notify the FDA and provide notice of discontinuance. Correspondence should be directed to Donovan F. Duggan at the Center for Drug Evaluation and Research/Office of Compliance. The