FDA Inspection 1050998 — CAO Group, Inc.
The FDA completed an inspection of CAO Group, Inc. on May 7, 2018 in West Jordan, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 7, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- West Jordan, UT (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 2935 | 21 CFR 812.43(b) | Sponsor shipped devices to unqualified person(s) |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 2950 | 21 CFR 812.46(a) | Device return/disposal by non-compliant investigator |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 3009 | 21 CFR 812.140(e) | Notice of transfer of responsibility for records |