FDA Inspection 1275087 — Shionogi Pharma Co., Ltd.
The FDA completed an inspection of Shionogi Pharma Co., Ltd. on July 1, 2025 in Isawa-Gun. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 1, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Isawa-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |