483
Jilin Asymchem Pharmaceuticals Co., Ltd.FDA 483 - Jilin Asymchem Pharmaceuticals Co., Ltd. - April 30, 2026
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Jilin Asymchem Pharmaceuticals Co., Ltd. in Dunhua, China, received an FDA Form 483 following an inspection. The observations primarily concern inadequate written procedures and adherence to cleaning and calibration protocols, as well as deficiencies in process validation activities for drug substance manufacturing. These issues indicate potential risks to product quality and consistency.
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ID · 5bd496db-dba6-4e5a-93f8-0d6d0cdd42c6