FDA inspection
Hubei Gedian Humanwell Pharmaceutical Co., Ltd.: FDA inspection ending Nov 7, 2025
FDA inspection 1295344 · Official Action Indicated (OAI) · Ezhou
Key facts
| Inspection ID | 1295344 |
|---|---|
| Firm | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. |
| FEI number | 3004117486 |
| Address | No. 25 Juxian Road; Gedian Development Zone |
| City | Ezhou |
| Country | China |
| Fiscal year | 2026 |
| Inspection end date | Nov 7, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 725591 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data