FDA Inspection 1274944 — Astellas Pharma Inc.
The FDA completed an inspection of Astellas Pharma Inc. on Jun 6, 2025 in Takaoka. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Takaoka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |