FDA Inspection 654085 — Advanced Image Enhancement, Inc.
The FDA completed an inspection of Advanced Image Enhancement, Inc. on March 26, 2010 in Fall River, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fall River, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |