1173306
Turbett Surgical, Inc. — FEI 3012421755
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Henrietta, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |