FDA Inspection
Ephraim McDowell Health IRBEphraim McDowell Health IRB – FDA Inspection, Jan 6, 2010
Record Details
This FDA Inspection record concerns Ephraim McDowell Health IRB, with an inspection on January 6, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ephraim McDowell Health IRB
- Inspection Date
- January 6, 2010
- Product Type
- Drugs
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ID · 283a6d2c-5217-43ea-913d-156b5cedbfb4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 638774
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
13- 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)(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 56.108(a)(1)Initial and continuing reviews
- 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
Showing 10 of 13 citations.
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Other FDA inspections of Ephraim McDowell Health IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 2, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ephraim McDowell Health IRB
- FDA Inspection 914134 - 2015-02-11
- FDA Inspection 713264 - 2011-03-02
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