948362
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |