FDA Inspection
Northeast Alabama Regional Medical Center IRBNortheast Alabama Regional Medical Center IRB – FDA Inspection, Apr 27, 2017
Record Details
This FDA Inspection record concerns Northeast Alabama Regional Medical Center IRB, with an inspection on April 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f3c091a1-9dff-410e-936b-327d1459f40a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011589
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.107(c)One scientific and one non-scientific member
Full citation text and observation details available on the Dashboard.
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 |
| July 20, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Northeast Alabama Regional Medical Center IRB
- FDA Inspection 1177749 - 2022-08-03
- FDA Inspection 791741 - 2012-07-20
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