FDA Inspection 589876 — Volk Optical Inc
The FDA completed an inspection of Volk Optical Inc on June 26, 2009 in Mentor, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |