1164125
Innovative Medical Equipment — FEI 3007353136
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |