FDA WARNING_LETTER - Sichuan Pharmaceutical Co., Ltd. - June 29, 2010

On September 9, 2011, the FDA issued a Warning Letter to Sichuan Pharmaceutical Co., Ltd. following a June 23-29, 2010 inspection of their API manufacturing facility in Pengzhou, China. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

A primary violation was the failure to implement appropriate procedures to prevent cross-contamination. Specifically, the firm manufactured (b)(4) API adjacent to workshops producing (b)(4) API and (b)(4) injection without adequate controls or monitoring. Additionally, a facility previously used for (b)(4) was utilized for (b)(4) API without sufficient decontamination, renovation, or activation, and cross-contamination risks were not adequately assessed. The FDA stated that analytical testing alone is insufficient.

The company's August 5 and December 13, 2010 responses were deemed insufficient. The FDA requires detailed plans for decontamination, renovation, and reactivation, including agents, methodologies, and supporting data.

Furthermore, the firm failed to register and list all APIs in commercial distribution in the U.S. with the FDA, as required by 21 C.F.R. § 207.40 and section 510(i) of the Act.