FDA Inspection
Cleveland Clinic Florida IRBCleveland Clinic Florida IRB – FDA Inspection, Oct 22, 2012
Record Details
This FDA Inspection record concerns Cleveland Clinic Florida IRB, with an inspection on October 22, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cleveland Clinic Florida IRB
- Inspection Date
- October 22, 2012
- Product Type
- Devices
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ID · e69d8c0a-7710-4c6c-9ec2-c37f636406c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806943
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(b)(2)Minor changes
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