483
Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site)FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site) - November 19, 2025
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Record Details
An FDA inspection of Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (Huanggang Site), a finished API manufacturer, revealed an inadequate cleaning validation program for manufacturing equipment. The firm lacked a complete Clean Hold Time study, raw data for surface area calculations, and proper justification for campaign cleaning. This inadequacy resulted in observed product residues and stains on equipment contact surfaces.
- Inspection Date
- November 19, 2025
- Product Type
- Drugs
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ID · 28405a11-43bb-4e95-aaf4-c508e1bae83b