FDA Inspection
Institutional Review Board of Franciscan Health LafayetteInstitutional Review Board of Franciscan Health Lafayette – FDA Inspection, Feb 13, 2013
Record Details
This FDA Inspection record concerns Institutional Review Board of Franciscan Health Lafayette, with an inspection on February 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 13, 2013
- Product Type
- Drugs
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ID · 8e9e4fcc-0a10-4c46-b9e3-c081da93958a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 818266
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 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 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Institutional Review Board of Franciscan Health Lafayette
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 3, 2014 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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