FDA Inspection 661652 — AOTI Ltd.
The FDA completed an inspection of AOTI Ltd. on April 22, 2010 in Galway. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Galway (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |