981670
Western/Scott Fetzer Company — FEI 1526809
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westlake, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |