1146624
Lima USA, Inc. — FEI 3009505046
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Arlington, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |