1149315
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 20, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lawrenceburg, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |