888099
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |