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# Warning Letter Issued After IRB Inspection
- URL: https://www.fdaweb.com/warning-letter-issued-after-irb-inspection/
- Published: 2019-07-12T12:00:00.000Z
- Updated: 2026-09-15T01:37:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144521

FDA has issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abington-memorial-hospital-irc-576854-06242019?ref=fdaweb.com) to Abington Memorial Hospital’s institutional review board after a bioresearch monitoring inspection found violations. For example, FDA said the IRB failed to review proposed research at convened meetings at which a majority of members of the IRB are present. The IRB was also cited for failing to prepare and maintain adequate documentation of its activities. The letter said minutes from a 3/2018 IRB meeting do not adequately document the IRB’s approval of an undisclosed study. “The study product is a significant risk device, but the meeting minutes indicate both that the study product is not a device and that the study product was determined to be a non-significant risk device,” it said.