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

Source: https://www.keypedia.com/records/warning_letter/zhejiang-jiuzhou-pharmaceutical-co-ltd/d6aee00f-a341-4a32-8adc-33ae5b663aa6

> FDA WARNING_LETTER for Zhejiang Jiuzhou Pharmaceutical Co., Ltd. on October 24, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
- Inspection Date: 2013-10-24
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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## Related Officers

- [Director - Division of Compliance](https://www.keypedia.com/people/eric-m-nelson/301ef659-ae6a-41c5-9a3e-9cfbc0369670)
- [Thomas J. Cosgrove](https://www.keypedia.com/people/thomas-j-cosgrove/616abec3-5ed9-42aa-9f5d-392b5552b695)

Company: https://www.keypedia.com/companies/zhejiang-jiuzhou-pharmaceutical-co-ltd/6ff21ff3-4c18-4e07-9c38-79e499bfb8fa

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c