FDA Inspection
Texas Applied Biotechnology Research Review CommitteeTexas Applied Biotechnology Research Review Committee – FDA Inspection, Apr 25, 2012
Record Details
This FDA Inspection record concerns Texas Applied Biotechnology Research Review Committee, with an inspection on April 25, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 25, 2012
- Product Type
- Biologics
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ID · 03936dc0-4aad-4fbe-b9ae-0b0c777e7943
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 782855
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 50.55(a)Adequate provisions for assent of children
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(b)(6)Number of subjects in study
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.111(a)(1)Risks minimized by sound research design
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