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483
•Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site)•November 19, 2025

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.

Company
Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site)
Inspection Date
November 19, 2025
Product Type
Drugs
Office
Office of Inspections and Investigations
Person
  • Dipesh K. Shah
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ID · 28405a11-43bb-4e95-aaf4-c508e1bae83b

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