FDA Inspection
Western Reserve Health Education IRBFDA Inspection 1110470 - Western Reserve Health Education IRB - November 20, 2019
Record Details
This FDA Inspection record concerns Western Reserve Health Education IRB, with an inspection on November 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2019
- Product Type
- Devices
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ID · 9952626b-ddd0-417c-9723-3d408c29b7ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110470
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of Western Reserve Health Education IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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