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# Pikeville IRB Did Not Follow Regs: FDA
- URL: https://www.fdaweb.com/pikeville-irb-did-not-follow-regs-fda/
- Published: 2016-04-12T12:00:00.000Z
- Updated: 2026-09-14T20:54:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135331

> An 8/17-8/21/15 FDA inspection at the Pikeville Medical Center Institutional Review Board (IRB) Pikeville, KY, found that the IRB did not adhere to applicable FDA regulations governing the protection of human subjects. A just-released 3/1 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm494229.htm?ref=fdaweb.com) says that violations shown on an FDA-483 included:  
> failing to prepare, maintain, and follow written procedures governing the functions and operations of the IRB; failing to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings; failing to review proposed research at convened meetings at which a majority of the IRB members are present, including at least one member whose primary concerns are in non-scientific areas; and failing to conduct continuing review of research at intervals of not less than once per year.  
>  
> The IRB was told to take specific steps to prevent similar violations in the future.