897654
Otsuka Pharmaceutical Development & Commercialization, Inc — FEI 3000718406
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |