FDA Inspection
Coast IRB LLCCoast IRB LLC – FDA Inspection, Apr 29, 2009
Record Details
This FDA Inspection record concerns Coast IRB LLC, with an inspection on April 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coast IRB LLC
- Inspection Date
- April 29, 2009
- Product Type
- Drugs
View Company Profile
ID · 7a229b7e-89df-49a9-82fa-9bb1299cb42b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 672654
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
7- 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 56.111(a)(2)Risks to subjects reasonable
- 21 CFR 56.107(a)At least five members with varying backgrounds
- 21 CFR 56.110(c)Method to keep members advised
- 21 CFR 812.66No IRB notification of significant risk determination
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