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# Amicis Research Didn’t Follow Investigation Plan: FDA
- URL: https://www.fdaweb.com/amicis-research-didnt-follow-investigation-plan-fda/
- Published: 2025-05-06T12:00:00.000Z
- Updated: 2026-09-14T15:11:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159121

A 2/12-2/16/2024 FDA Bioresearch Monitoring Program inspection at Amicis Research Center, operated by Dr. **Nana Barseghian** in Northridge, CA, found that Barseghian failed to ensure that a clinical investigation was conducted according to the investigational plan. A 4/28 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nana-barseghian-mdamicis-research-center-708009-04282025?ref=fdaweb.com) acknowledges the corrective and preventive actions the site has taken, but says Barseghian’s response to the inspection observation was inadequate because it did not include sufficient details about the corrective action plan.

Barseghian was told to respond with a list of specific actions that have been taken to prevent similar violations in the future.