FDA Inspection
Our Lady Of Bellefonte Hosp IRBOur Lady Of Bellefonte Hosp IRB – FDA Inspection, Jan 6, 2012
Record Details
This FDA Inspection record concerns Our Lady Of Bellefonte Hosp IRB, with an inspection on January 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 6, 2012
- Product Type
- Drugs
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ID · 178031b3-2ee6-4d75-bcfc-4415c377c2e6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 762659
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
15- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.106(b)(2)IRB chairperson information
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
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