1187252
Wexler Surgical, Inc. — FEI 1000160162
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |