FDA Inspection 1277764 — Sumitomo Pharma Co., Ltd.
The FDA completed an inspection of Sumitomo Pharma Co., Ltd. on August 7, 2025 in Suzuka. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suzuka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |