FDA Inspection
Arnot Health IRBArnot Health IRB – FDA Inspection, Jan 13, 2012
Record Details
This FDA Inspection record concerns Arnot Health IRB, with an inspection on January 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Arnot Health IRB
- Inspection Date
- January 13, 2012
- Product Type
- Drugs
View Company Profile
ID · 297b0aba-590c-4542-9153-daac40d79b45
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 764486
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
13- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.106(e)Changes in contact or chairperson information
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.109(a)Authority of the IRB
- 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)(3)Prompt reporting of changes
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