FDA WARNING_LETTER - Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta - March 11, 2024

The FDA issued a Warning Letter to Dr. Flamini following an inspection from February 28 to March 11, 2024, as part of the Bioresearch Monitoring Program. The inspection reviewed the conduct of clinical investigations, specifically Protocol (b)(4). The FDA found that Dr. Flamini failed to ensure the investigation was conducted according to the investigational plan, violating 21 CFR 312.60.

A key deficiency involved Subject (b)(6), a 15-year-old female, who received approximately 10 times the maximum daily dose of investigational drug (b)(4) for seven days, exposing her to increased risk of adverse events. The protocol required a weight-based dose of 0.2 mg/kg, not exceeding 12.5 mg/day, but the subject received 120 mg/day.

Dr. Flamini's March 25, 2024, response to the Form FDA 483 acknowledged the overdose and stated immediate actions were taken, including contacting the Legally Authorized Representative and reducing the dosage. The response also cited the lack of an electronic dose calculator and safety guards in the dispensing algorithm. A Corrective and Preventive Action (CAPA) plan was established, including a new SOP for medication dispensation, emphasizing dose calculation collaboration, protocol adherence verification, and detailed patient instructions.

However, the FDA deemed the response inadequate due