FDA Inspection
Solutions IRB LLCSolutions IRB LLC – FDA Inspection, Aug 15, 2014
Record Details
This FDA Inspection record concerns Solutions IRB LLC, with an inspection on August 15, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Solutions IRB LLC
- Inspection Date
- August 15, 2014
- Product Type
- Drugs
View Company Profile
ID · ded39f53-4148-4322-9c8b-92d08198a655
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893385
- 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)(2)Minutes of IRB meetings
- 21 CFR 56.111(a)(6)Monitoring of data collected
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(c)Method to keep members advised
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