FDA WARNING_LETTER - Shirish M. Gadgeel, MD - August 23, 2024

The FDA issued a Warning Letter to Dr. Gadgeel at 2799 West Grand Boulevard, Detroit, following an inspection from August 5 to August 23, 2024. The inspection, part of the FDA’s Bioresearch Monitoring Program, identified significant non-compliance with the Federal Food, Drug, and Cosmetic Act and Title 21 CFR Part 312 regulations governing clinical investigations.

Key violations included failure to adhere to the investigational plan requirements. Specifically, Dr. Gadgeel enrolled a subject in Protocol (b)(4) without confirming eligibility criteria, and continued treatment for another subject despite confirmed disease progression, contrary to protocol stipulations. The investigational plan required subjects to meet all eligibility criteria before enrollment and mandated removal from treatment upon disease progression.

In response, Dr. Gadgeel acknowledged these lapses and outlined corrective actions, including refresher training for staff on protocol compliance, hiring additional research staff for eligibility review, and revising workflows to ensure systematic eligibility assessments. Additionally, measures were taken to ensure treatment beyond progression is permissible only with sponsor and IRB approval.

The FDA emphasized the importance of adhering to investigational plans to protect human subjects and maintain data integrity. Dr. Gadgeel is required to implement these corrective actions to address the noted deficiencies and ensure compliance with regulatory requirements.