FDA WARNING_LETTER - Peter Michael, M.D./G+C Research Group - June 11, 2024

On June 18, 2025, the FDA issued a Warning Letter to Peter Michael, M.D./G+C Research Group, following an inspection from June 3 to June 11, 2024. The inspection, part of the Bioresearch Monitoring Program, reviewed clinical investigations for investigational drug (b)(4) under Protocol (b)(4) and investigational drug (b)(4) under Protocol (b)(4).

The primary violation cited was the failure to ensure the investigation was conducted according to the investigational plan, specifically 21 CFR 312.60. For Protocol (b)(4), two pediatric subjects, a 9-year-old female and a 9-year-old male, were administered 3 mg/day of (b)(4) oral solution, exceeding the protocol's maximum allowed dose of 1.5 mg/day. This exposed them to increased risk of adverse events.

Dr. Michael's June 26, 2024, response to the FDA 483 attributed the overdosing to misinterpretation and stated that doses were adjusted, and subjects screened with no reported adverse events. A Corrective and Preventive Action (CAPA) plan was implemented, including staff retraining on dosing, contacting the sponsor for vague protocol details, and additional pharmacy staff for dose double-checking.

The FDA deemed the response inadequate, lacking sufficient