FDA Inspection 940228 — Arrotek Medical Ltd
The FDA completed an inspection of Arrotek Medical Ltd on July 30, 2015 in Sligo. 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
- July 30, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sligo (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |