FDA Inspection
Western Reserve Health Education IRBFDA Inspection 806424 - Western Reserve Health Education IRB - November 09, 2012
Record Details
This FDA Inspection record concerns Western Reserve Health Education IRB, with an inspection on November 9, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 9, 2012
- Product Type
- Drugs
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ID · e9abefa2-84b9-4196-ad1d-6144125cdca0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806424
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
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Other FDA inspections of Western Reserve Health Education IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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