An inspection by the US Food and Drug Administration (FDA) in October last year of Zhejiang’s API facility in Taizhou, China led to a warning letter being issued earlier this month citing a number of cGMP and misbranding violations.
“Your firm prepared a certificate of analysis (COA) for gabapentin on your firm’s letterhead, indicating that the product was manufactured by your firm, Zhejiang Jiuzhou Pharmaceutical Co., Ltd, when in fact it was not,” the letter said.
Instead, the anticonvulsant and analgesic API gabapentin was found to have been manufactured by an undisclosed API maker. Furthermore, Zhejiang Jiuzhou relabeled gabapentin and included on the label an official stamp that identified itself as the manufacturer, and thus the API is “misbranded in that its labeling is false or misleading.”
The import/export company, Zhejiang Zonebanner Jiuzhou, which operates from the same site, was also cited for failing to “implement an effective system of managing quality” and failing to “transfer all quality or regulatory information received from the API manufacturer to customers.”
The letter continued: “Zonebanner had no quality system in place for the relabeling operations. In addition, we note that in at least one instance of a lot of gabapentin shipped to the US, the retest date from the original manufacturer’s certificate of analysis (November 2013) was changed to an expiration date listed as eleven months later (October 2014) on the new certificate of analysis.”
Zhejiang Jiuzhou had responded to the FDA implying Zonebanner is a separate legal entity under Chinese law, but the FDA rebutted the comments considering the import/export firm to be under Zhejiang Jiuzhou’s control.
The FDA found the company had also failed to review batch production records prior to distribution of an API batch, failed to document manufacturing operations at the time they are performed, and failed to adequately maintain equipment in a state appropriate for its intended use in the manufacture of APIs.
For the latter, a leak in the purified water system was found whilst other pieces of manufacturing equipment were in need of repair.
The warning letter is the third to be issued to an API or finished formulation manufacturer in China, Hong Kong and Taiwan this year, and the eleventh since January 2012.
As of last November, the FDA had a team of eight inspectors based in China. Though budget has since been allocated to increase this number, Dennis Shea – Chairman of the US-China Economic and Security Review Commission (USCC) – said ensuring Chinese products are safe through the inspection of over 4,000 Chinese plants that ship APIs to the US is a “hopeless task.”