FDA Inspection 758825 — American Imex
The FDA completed an inspection of American Imex on December 16, 2011 in Irvine, CA. 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
- December 16, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3837 | 21 CFR 820.25(b) | Training records |