FDA Inspection
Floyd Medical Center IRCFloyd Medical Center IRC – FDA Inspection, Jul 12, 2012
Record Details
This FDA Inspection record concerns Floyd Medical Center IRC, with an inspection on July 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Floyd Medical Center IRC
- Inspection Date
- July 12, 2012
- Product Type
- Devices
View Company Profile
ID · 04bbeccd-ad46-495a-9c25-de55b5cfdb21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 790354
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
9- 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 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.110(c)Method to keep members advised
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