FDA Inspection
MMC Health Systems, Inc. IRBMMC Health Systems, Inc. IRB – FDA Inspection, Aug 7, 2015
Record Details
This FDA Inspection record concerns MMC Health Systems, Inc. IRB, with an inspection on August 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MMC Health Systems, Inc. IRB
- Inspection Date
- August 7, 2015
- Product Type
- Devices
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ID · 59ae7df1-4dae-49e7-add4-ba26a9925f05
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943318
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 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
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