FDA Inspection 845184 — Advanced Magnetic Research Institute International LLC
The FDA completed an inspection of Advanced Magnetic Research Institute International LLC on September 10, 2013 in Las Vegas, NV. 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
- 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 |