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# Atlanta Doctor’s Research Didn’t Follow Plan: FDA
- URL: https://www.fdaweb.com/atlanta-doctors-research-didnt-follow-plan-fda/
- Published: 2024-09-03T12:00:00.000Z
- Updated: 2026-09-14T14:40:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157693

A 2/28-3/11 FDA Bioresearch Monitoring Program inspection at the Clinical Integrative Research Center of Atlanta operated by Dr. **Julio Flamini** in Atlanta, GA, found objectionable conditions related to two clinical investigations. An 8/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/julio-r-flamini-mdclinical-integrative-research-center-atlanta-691123-08202024?ref=fdaweb.com) says Flamini failed to ensure that the investigations were conducted according to the investigational plan. FDA acknowledges corrective and preventive actions Flamini has taken, but says his response to the investigation observations was inadequate because it lacked sufficient details about the corrective action plan.

“We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan,” the letter says, “to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to conduct the clinical study in accordance with the protocol resulted in an overdose to a pediatric patient. This conduct raises significant concerns about your protection of the study subjects enrolled at your site, and also raises concerns about the validity and integrity of the data collected at your site.”

Flamini was told to respond with a list of specific actions he has taken to prevent similar violations in the future.