FDA Inspection
Integris Southwest Medical Center IRBIntegris Southwest Medical Center IRB – FDA Inspection, Dec 14, 2009
Record Details
This FDA Inspection record concerns Integris Southwest Medical Center IRB, with an inspection on December 14, 2009, covering drugs.
- Inspection Date
- December 14, 2009
- Product Type
- Drugs
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ID · 816ff807-9bf5-4705-9f52-c6dc23793bbd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634075
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(3)Prompt reporting of changes
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