FDA Inspection 994655 — Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Otsuka Pharmaceutical Co., Ltd. on September 22, 2016 in Naka-Gun. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Naka-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |