FDA WARNING_LETTER - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. - October 24, 2013

The FDA issued a Warning Letter to Zhejiang Jiuzhou Pharmaceutical Co., Ltd. and its import/export company, Zhejiang Zonebanner Jiuzhou Imp. & Exp. Co., Ltd., following an inspection from October 21-24, 2013. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated.

Key violations include:

* **Zonebanner's Failure to Manage Quality and Obscure Supply Chain:** Zonebanner, despite being under Zhejiang Jiuzhou's control, relabeled APIs from outside suppliers with Zhejiang Jiuzhou's letterhead and new labels, omitting original manufacturer information. They lacked a quality system for relabeling, and in one instance, extended the retest date of gabapentin to an unsupported expiration date. * **Zhejiang Jiuzhou's Quality Unit Deficiencies:** The quality unit failed to review batch production records before API distribution, with several lots shipped prior to release. Internal reviews were deemed insufficient due to poor documentation practices. * **Failure to Document Operations and Data Falsification:** Manufacturing operations were not documented at the time performed, with missing or belated entries. An employee admitted to falsifying a CGMP record by signing off on a batch record review they had not performed. * **Inadequate Equipment Maintenance:** The purified water system had leaks, a recurring issue from a previous