866413
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3159 | 21 CFR 820.184 | DHR content |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |