483
Xinyu Pharmaceutical Co., Ltd.FDA 483 - Xinyu Pharmaceutical Co., Ltd. - June 27, 2025
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Jinyu Pharmaceutical Co., Ltd. in Suzhou, China, an API manufacturer, was inspected by the FDA from June 23-27, 2025. The inspection revealed significant deficiencies in quality assurance oversight, equipment identification and maintenance, and stability sample management. These issues indicate a lack of robust quality system controls for API manufacturing.
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ID · 93161494-c852-4989-b601-9734af6bdd03