FDA 483 - Ferring Pharmaceuticals (China) Co., Ltd - August 22, 2025
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An FDA inspection of Ferring Pharmaceuticals (China) Corporation Ltd., a sterile diluent manufacturer in Zhongshan, China, revealed significant deficiencies. Observations included issues with equipment design and qualification, specifically bent components lacking individual IDs and capping machine qualification based on unscientific justification. Additionally, the firm lacked appropriate controls over computer systems, with unverified and undocumented backups of manufacturing data.
ID · 17422f02-e35b-4016-8942-7745143337fc