FDA Inspection
Borgess Medical Center Institutional Review BoardBorgess Medical Center Institutional Review Board – FDA Inspection, Jun 15, 2010
Record Details
This FDA Inspection record concerns Borgess Medical Center Institutional Review Board, with an inspection on June 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 15, 2010
- Product Type
- Devices
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ID · a03db3b6-9afc-43d7-b13c-597efe35a3bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672838
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.111(b)Vulnerable subject safeguards
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(c)Method to keep members advised
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