FDA Inspection
Pikeville Medical Center Inc Institutional Review CommitteePikeville Medical Center Inc Institutional Review Committee – FDA Inspection, Aug 21, 2015
Record Details
This FDA Inspection record concerns Pikeville Medical Center Inc Institutional Review Committee, with an inspection on August 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 21, 2015
- Product Type
- Drugs
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ID · b2409d11-e547-4532-a978-9e8ebffef1df
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 940678
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
14- 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 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.106(b)(2)IRB registration information
- 21 CFR 56.106(e)Changes in contact or chairperson information
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(3)Prompt reporting of changes
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Other FDA inspections of Pikeville Medical Center Inc Institutional Review Committee
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Pikeville Medical Center Inc Institutional Review Committee
- FDA Inspection 1026901 - 2017-09-20
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