FDA Inspection
The Baylor Scott & White Research Institute IRB, TempleThe Baylor Scott & White Research Institute IRB, Temple – FDA Inspection, May 3, 2013
Record Details
This FDA Inspection record concerns The Baylor Scott & White Research Institute IRB, Temple, with an inspection on May 3, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 3, 2013
- Product Type
- Drugs
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ID · c6699613-d620-43ac-8e9d-56d273ee77a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829511
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 50.51Provisions for soliciting assent and permission
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 50.52Factors required for approval
- 21 CFR 56.107(a)At least five members with varying backgrounds
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Other FDA inspections of The Baylor Scott & White Research Institute IRB, Temple
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2024 | NAI | Bioresearch Monitoring | |
| August 18, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for The Baylor Scott & White Research Institute IRB, Temple
- FDA Inspection 1227695 - 2024-01-10
- FDA Inspection 1023639 - 2017-08-18
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