FDA Inspection 994655 — Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Otsuka Pharmaceutical Co., Ltd. on Sep 22, 2016 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Naka-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |