FDA Inspection 1221183 — Astellas Pharma Inc.
The FDA completed an inspection of Astellas Pharma Inc. on Oct 27, 2023 in Yaizu. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 27, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yaizu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |