483
Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API).Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). – FDA 483, Aug 23, 2019
Record Details
An FDA inspection of Zhejiang Xianju Pharmaceutical Co., Ltd in Xianju, China, revealed one observation concerning the lack of audit trail review for critical analytical instruments. These instruments are used for release testing of APIs destined for the U.S. market, indicating a potential issue with data integrity and quality control practices.
- Inspection date
- August 23, 2019
- Product type
- drugs
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ID · 6f57f486-b578-4d59-93df-ebd528be8ab2
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