FDA Inspection
Baylor St Luke's Medical Center IRB & ResearchBaylor St Luke's Medical Center IRB & Research – FDA Inspection, Aug 14, 2014
Record Details
This FDA Inspection record concerns Baylor St Luke's Medical Center IRB & Research, with an inspection on August 14, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 14, 2014
- Product Type
- Biologics
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ID · d456014b-91fc-4054-916b-6de9c8b621c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 890591
- FDA center
- Biologics
- 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 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.107(d)One non-affiliate member
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