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# IRB Violations Seen in FDA-483s
- URL: https://www.fdaweb.com/irb-violations-seen-in-fda-483s/
- Published: 2024-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:46:23.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158141

FDA has released its analysis of FY 2023 institutional review board (IRB) violations based on the form FDA-483s that were issued. The [report](https://www.fda.gov/media/183351/download?ref=fdaweb.com) says that broadly written regulations do not always convey the specific details of the observed violations. The agency says it reviewed and sub-categorized FDA-483 citations into more granular themes to identify trends.

Out of 72 IRB inspections in FY 2023, 15 received a form FDA-483\. The themes identified from the data were:

- IRB communications/meeting minutes deficiencies;
- no or not following written procedures;
- IRB membership deficiencies; and
- operational deficiencies.