FDA Inspection 961508 — Sato Pharmaceutical Co., Ltd.
The FDA completed an inspection of Sato Pharmaceutical Co., Ltd. on February 12, 2016 in Hachioji. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 12, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hachioji (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |