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# Bioresearch Monitoring Violations Found
- URL: https://www.fdaweb.com/bioresearch-monitoring-violations-found/
- Published: 2026-09-08T12:00:00.000Z
- Updated: 2026-09-13T19:20:22.000Z
- Author: David McFarland
- Tags: enforcement, #legacy-id-D5161740

A 6/2-6/13/2025 FDA Bioresearch Monitoring Program inspection of a clinical trial conducted by **Stephen Fallon** in Wilton Manors, FL, found that Fallon violated regulations governing the proper conduct of clinical studies involving investigational products. An 8/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stephen-j-fallon-phd-728673-08272026?ref=fdaweb.com) says the specific violations were:

- failure to properly obtain and document informed consent;
- revising and implementing an informed consent form without obtaining institutional review board approval;
- failure to ensure that the investigation was conducted according to the signed agreement with the sponsor and the investigational plan; and
- failure to maintain accurate, complete, and current records relating to Fallon’s participation in the study.

FDA says that because Fallon did not provide a response to the investigation observations, the agency is unable to evaluate his perspective on the findings, his explanations for the deficiencies, or his commitment to implementing further measures to prevent similar problems in the future, along with a clear timeline to achieve any planned implementation.

FDA also noted that Fallon said he did not intend to continue as a clinical investigator at Latinos Salud, Inc., to conduct clinical studies of FDA-regulated products. “Regardless of your intention to discontinue your participation in clinical trials of FDA-regulated products, we advise that you provide us with a response to the … violations,” the letter says.

Fallon was told to respond with a list of specific actions he has taken or plans to take to correct the violations and prevent similar violations, with documentation of the actions and a schedule for completing them.