FDA Inspection 1230640 — Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. on March 22, 2024 in Tokushima. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 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) |