FDA Inspection 969068 — MEDTRONIC IRELAND
The FDA completed an inspection of MEDTRONIC IRELAND on Feb 12, 2016 in Galway. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Galway (Ireland)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |