Amphastar Nanjing Pharmaceuticals, Inc.
Amphastar Nanjing Pharmaceuticals, Inc. has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Mar 7, 2025 · NAI
- Latest 510(k)
- Feb 12, 2021
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
| Inspections | 5 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 7, 2025 | Nanjing, China | Drugs | No Action Indicated (NAI) | 3009805706 |
| Oct 11, 2019 | Nanjing, China | Drugs | Voluntary Action Indicated (VAI) | 3009805706 |
| Oct 26, 2017 | Nanjing, China | Drugs | No Action Indicated (NAI) | 3009805706 |
| Apr 29, 2016 | Nanjing, China | Drugs | No Action Indicated (NAI) | 3009805706 |
| Apr 4, 2014 | Nanjing, China | Drugs | Voluntary Action Indicated (VAI) | 3009805706 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K201545 | Surgical Face Mask | Feb 12, 2021 |