FDA Inspection 943826 — Cyber Medical Imaging Inc
The FDA completed an inspection of Cyber Medical Imaging Inc on Sep 28, 2015 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 28, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |