663430
Innovative Medical Equipment — FEI 3007353136
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 18, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |