845184
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Las Vegas, NV (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2995 | 21 CFR 812.140(b)(4) | Availability of records of non-significant risk studies |
| 2996 | 21 CFR 812.140(b)(4)(i) | Sponsor records re device use in non-significant risk study |
| 2999 | 21 CFR 812.140(b)(4)(iv) | Sponsor records of non-significant risk study IRBs |
| 3000 | 21 CFR 812.140(b)(4)(v) | Sponsor records re QSR/GMP & non-significant risk studies |
| 3038 | 21 CFR 812.150(b)(1) | Sponsor evaluation rpt not timely, distributed |
| 3048 | 21 CFR 812.150(b)(5) | Sponsor progress reports for non-significant risk study |
| 3052 | 21 CFR 812.150(b)(6) | Sponsor notif. of rqst. to return/repair/dispose not made |
| 7017 | 21 CFR 812.150(b)(7) | Sponsor final report for non-significant risk study |