FDA Inspection
Del Sol Medical Center IRBDel Sol Medical Center IRB – FDA Inspection, May 5, 2010
Record Details
This FDA Inspection record concerns Del Sol Medical Center IRB, with an inspection on May 5, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Del Sol Medical Center IRB
- Inspection Date
- May 5, 2010
- Product Type
- Drugs
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ID · 8edff457-666e-47c1-b4b7-af97f83c67e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658430
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(f)Continuing review
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