FDA inspection
Amphastar Nanjing Pharmaceuticals Inc: FDA inspection ending Sep 19, 2025
FDA inspection 1291882 · Official Action Indicated (OAI) · Nanjing
Key facts
| Inspection ID | 1291882 |
|---|---|
| Firm | Amphastar Nanjing Pharmaceuticals Inc |
| FEI number | 3009805706 |
| Address | Nanjing Economic, No 5 Xinghe Road; And Technological Development Zone |
| City | Nanjing |
| Fiscal year | 2025 |
| Inspection end date | Sep 19, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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