FDA Inspection 576084 — Otsuka Pharmaceutical Development & Commercialization, Inc
The FDA completed an inspection of Otsuka Pharmaceutical Development & Commercialization, Inc on Apr 14, 2009 in Rockville, MD. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4058 | 21 CFR 820.20 | Management responsibility |