1018239
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rush, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |