FDA Inspection
Aultman Health Foundation HRRBAultman Health Foundation HRRB – FDA Inspection, Jun 28, 2017
Record Details
This FDA Inspection record concerns Aultman Health Foundation HRRB, with an inspection on June 28, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ca10db85-3d15-4eec-a237-12ea673a225d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016235
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.110(b)Research not eligible for expedited review
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Other FDA inspections of Aultman Health Foundation HRRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2023 | NAI | Bioresearch Monitoring | |
| March 8, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Aultman Health Foundation HRRB
- FDA Inspection 1207758 - 2023-05-22
- FDA Inspection 771310 - 2012-03-08
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