FDA warning letter to Chinese API Manufacturer for cGMP and Misbranding Violations

The US Food and Drug Administration (FDA) issued a Warning Letter to Zhejiang Jiuzhou Pharmaceutical Co, based in Taizhou, Zhejiang Province, China, for violations of good manufacturing practices (GMPs) and misbranding of products.The inspection was conducted during October 21 to 24, 2013 at API manufacturer Zhejiang Jiuzhou Pharmaceutical Co., Ltd., and its import/export company Zhejiang ZonebannerJiuzhou Imp. & Exp. Co., Ltd., both located in Zhejiang Province.

According to the warning letter, the FDA investigator observed a failure by ZonebannerJiuzhou Imp. & Exp. Co to implement an effective system of managing quality and failure to transfer all quality or regulatory information received from the API manufacturer to its customers.The company purchased APIs from an outside supplier and relabeled them without the oversight of a quality unit. The information from the original certificate of analysis, generated by the actual manufacturer, was transferred to a new certificate of analysis on Zhejiang Jiuzhou Pharmaceutical Co. letterhead with no information about the original manufacturer or analytical laboratory performing the analyses.In addition, a new label identifying Zhejiang Jiuzhou Pharmaceutical Co. as the manufacturer was added to drums.

The FDA stated that in at least one instance of a lot of gabapentin shipped to the United States, the retest date from the original manufacturer’s certificate of analysis (November 2013) was changed to an expiration date listed as 11 months later (October 2014) on the new certificate of analysis.FDA investigator noted a leak in the purified water (PW) system during the inspection. FDA also found other pieces of manufacturing equipment in need of repair and indicated that the agency would review the effectiveness of the company’s revised preventive maintenance program during a future inspection.The FDA also cited the firm for failing to document manufacturing operations at the time that they were performed.