1163303
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kenosha, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |