Areva Pharmaceuticals Inc
FDA Regulatory Profile
Areva Pharmaceuticals Inc has 1 FDA recall, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0270-2021 · Class II · Nov 19, 2020
- Latest inspection
- Sep 11, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0270-2021 | Class II | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only… | Nov 19, 2020 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3009960162 | Georgetown, IN | 1 | Sep 11, 2025 |