FDA Inspection
Benefis Health System, IRBBenefis Health System, IRB – FDA Inspection, Sep 29, 2010
Record Details
This FDA Inspection record concerns Benefis Health System, IRB, with an inspection on September 29, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Benefis Health System, IRB
- Inspection Date
- September 29, 2010
- Product Type
- Drugs
View Company Profile
ID · b01b3897-2e17-49fe-9909-ee5a56b096aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685369
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 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 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(b)(2)Minor changes
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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