FDA Inspection 980250 — Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Otsuka Pharmaceutical Co., Ltd. on Jul 22, 2016 in Itano-Gun. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Itano-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |