FDA Inspection 1107691 — Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Otsuka Pharmaceutical Co., Ltd. on Oct 22, 2019 in Naka-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
- Oct 22, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Naka-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 |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |