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Talk to a SpecialistTalk to a SpecialistDr. Kevin R. Bender and DBC Research Corporation were cited for failing to adequately protect investigational drug products subject to the Controlled Substances Act from theft or diversion, and for failing to conduct clinical investigations according to their approved investigational plans, as required under 21 CFR 312.60 and 312.69. The violations were identified during an FDA Bioresearch Monitoring Program inspection conducted in December 2022 at the clinical research site in Tamarac, Florida, which reviewed the conduct of three clinical investigation protocols. Despite Dr. Bender's January 2023 response to the FDA Form 483 observations, the agency determined that the objectionable conditions represented a failure to adhere to applicable statutory requirements under the FD&C Act and Title 21 Code of Federal Regulations Part 312.