483
Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site)Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site) – FDA 483, Nov 19, 2025
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
View Company Profile
ID · 28405a11-43bb-4e95-aaf4-c508e1bae83b
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.