FDA Inspection 1230640 — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. on Mar 22, 2024 in Tokushima. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 22, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tokushima (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |