1276751
Enthermics Medical Systems, Inc. — FEI 1000116410
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Menomonee Falls, WI (United States)
Citations
| ID | CFR | Description |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |