1027501
Volk Optical Inc — FEI 1000122772
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 28, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |