FDA WARNING_LETTER - Kevin R. Bender, M.D./DBC Research Corporation - December 16, 2022

The FDA issued a Warning Letter to Dr. Bender following an inspection from December 5-16, 2022, concerning the conduct of clinical investigations under the Bioresearch Monitoring Program. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312.

The primary violations include failure to take adequate precautions to prevent theft or diversion of an investigational drug subject to the Controlled Substances Act (21 CFR 312.69) and failure to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60). Specifically, 110 kits of investigational drug (b)(4), a Schedule III controlled substance, were reported missing due to customer/nonemployee theft. The drug was not stored in a securely locked, substantially constructed cabinet with limited access as required by regulations and Protocol (b)(4). The shipment was stored outside the designated locked cabinet in a locked room accessible to unauthorized individuals.

Dr. Bender's January 4, 2023, response acknowledged a breach in storage procedures and a comprehensive investigation, but the FDA deemed it inadequate. The response lacked sufficient details on how access to secure areas for investigational product would be limited to appropriate personnel and did not detail planned or completed training on responsible conduct of clinical trials or FDA compliance.

The FDA emphasized that these failures raise significant concerns about the protection of study subjects and the