FDA Inspection 1017001 — Vision Diagnostics Inc
The FDA completed an inspection of Vision Diagnostics Inc on May 17, 2017 in Branford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Branford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |