FDA Inspection
Advanced Magnetic Research Institute International LLCAdvanced Magnetic Research Institute International LLC – FDA Inspection, Sep 10, 2013
Record Details
This FDA Inspection record concerns Advanced Magnetic Research Institute International LLC, with an inspection on September 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 10, 2013
- Product Type
- Devices
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ID · c644aa67-4056-47da-90c1-91695898de67
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 845184
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
10- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 812.150(b)(7)Sponsor final report for non-significant risk study
- 21 CFR 812.150(b)(5)Sponsor progress reports for non-significant risk study
- 21 CFR 812.140(b)(4)Availability of records of non-significant risk studies
- 21 CFR 812.140(b)(4)(v)Sponsor records re QSR/GMP & non-significant risk studies
- 21 CFR 812.140(b)(4)(iv)Sponsor records of non-significant risk study IRBs
- 21 CFR 812.140(b)(4)(i)Sponsor records re device use in non-significant risk study
- 21 CFR 812.150(b)(6)Sponsor notif. of rqst. to return/repair/dispose not made
- 21 CFR 812.150(b)(1)Sponsor evaluation rpt not timely, distributed
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Other FDA inspections of Advanced Magnetic Research Institute International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2016 | Not classified | San Francisco District Office | Project Evaluation: Devices |
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