FDA Inspection 936430 — Advanced Vision Science Inc
The FDA completed an inspection of Advanced Vision Science Inc on Aug 3, 2015 in Goleta, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 3, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Goleta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |