FDA Inspection
Mercy Medical Center IRBMercy Medical Center IRB – FDA Inspection, May 13, 2009
Record Details
This FDA Inspection record concerns Mercy Medical Center IRB, with an inspection on May 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mercy Medical Center IRB
- Inspection Date
- May 13, 2009
- Product Type
- Devices
View Company Profile
ID · 970e5d1c-1a93-4bd1-88cb-65cdb16a958b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 580463
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(f)Continuing review
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