FDA Inspection
Griffin Hospital/IRBGriffin Hospital/IRB – FDA Inspection, Feb 7, 2012
Record Details
This FDA Inspection record concerns Griffin Hospital/IRB, with an inspection on February 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Griffin Hospital/IRB
- Inspection Date
- February 7, 2012
- Product Type
- Devices
View Company Profile
ID · 6165c236-a1bf-4b38-9813-f4215f3d4fff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767815
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 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 56.108(a)(4)Changes in approved research
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