FDA Inspection
Genetics & IVF Institute IRBGenetics & IVF Institute IRB – FDA Inspection, Oct 1, 2009
Record Details
This FDA Inspection record concerns Genetics & IVF Institute IRB, with an inspection on October 1, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Genetics & IVF Institute IRB
- Inspection Date
- October 1, 2009
- Product Type
- Devices
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ID · 17dd9c13-3ef3-4056-8ff5-d078c575d807
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 616646
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.111(a)(2)Risks to subjects reasonable
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(c)Method to keep members advised
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