FDA Inspection
Northeast Alabama Regional Medical Center IRBNortheast Alabama Regional Medical Center IRB – FDA Inspection, Jul 20, 2012
Record Details
This FDA Inspection record concerns Northeast Alabama Regional Medical Center IRB, with an inspection on July 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 20, 2012
- Product Type
- Devices
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ID · 942e669d-1719-4103-b5b3-8519e2e19b5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791741
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
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Other FDA inspections of Northeast Alabama Regional Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 27, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Northeast Alabama Regional Medical Center IRB
- FDA Inspection 1177749 - 2022-08-03
- FDA Inspection 1011589 - 2017-04-27
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