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

Source: https://www.keypedia.com/records/483/hubei-gedian-humanwell-pharmaceutical-co-ltd-huanggang-site/28405a11-43bb-4e95-aaf4-c508e1bae83b

> FDA 483 for Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site) on November 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubei Gedian Humanwell Pharmaceutical Co., Ltd (Huanggang Site)
- Inspection Date: 2025-11-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/hubei-gedian-humanwell-pharmaceutical-co-ltd-huanggang-site/7bd5f28f-eb7d-4437-b183-6e0d6c81fe54

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8