1016788
Galix Biomedical Instrumentation, Inc. — FEI 3001673090
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 3, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |