887569
Medicomp, Inc. dba ReactDX — FEI 1033601
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 16, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |