FDA Inspection 1079491 — Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Otsuka Pharmaceutical Co., Ltd. on Feb 15, 2019 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 15, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Itano-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |