1218835
First Source Inc — FEI 3004063527
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 5450 | 21 CFR 1020.30(h)(2)(i) | Tube housing assemblies (leakage technique factors) |
| 5453 | 21 CFR 1020.30(h)(2)(ii) | Tube housing assemblies - cooling curves |
| 5814 | 21 CFR 1002.30(a)(2) | Basis for selecting methods, devices, procedures |