FDA Inspection 661820 — Event Medical Ltd
The FDA completed an inspection of Event Medical Ltd on April 16, 2010 in Galway. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Galway (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3195 | 21 CFR 820.30(g) | Design validation unresolved discrepancies |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |