FDA 483 - Qingdao Kangyuan Pharmaceutical Co. Ltd. - August 16, 2024
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Qingdao Kangyuan Pharmaceutical Co. Ltd., an API drug manufacturer in Jiaozhou City, China, was cited for significant deficiencies across its laboratory, production, and equipment systems. Observations included inadequate water system monitoring and microbial testing, insufficient detail and time limits in batch production records, and failure to validate analytical methods. Additionally, the firm's manufacturing equipment was not maintained in a good state of repair, posing contamination risks.
ID · e31e5b56-2548-42d7-969e-161523797700