FDA EIR - Donna S. Hrozencik, M.D. - January 26, 2022

An FDA surveillance inspection of Donna S. Hrozencik, M.D., a clinical investigator located in Canton, MI, was conducted from January 13-26, 2022. The inspection, requested by the Center for Drug Evaluation and Research (CDER) and conducted under compliance program 7348.811 (related to clinical investigations for new drug applications), focused on verifying submitted data, protocol adherence, informed consent, safety reporting, and record-keeping, referencing regulatory requirements such as 21 CFR Part 312.

The inspection concluded with the issuance of an FDA Form 483, detailing five main observations. These included significant protocol noncompliance, such as a subject receiving double the investigational drug dose, failure to provide essential medical supplements, and missed required bone density scans. The investigator also failed to promptly report an unanticipated event (drug dosing error) to the Institutional Review Board (IRB) and implemented research changes, like an unapproved research biopsy, without prior IRB approval. Additionally, the firm failed to prepare and maintain adequate and accurate case histories, evidenced by missing source records and discrepancies with the electronic data capturing system. Lastly, investigational records were not retained as required, with archived electronic trial data found to be missing.

Management discussions at the close of the inspection emphasized the critical importance of ensuring attributable, legible, and accurate source documentation, robust quality assurance in record-keeping and sample handling, and strict adherence to protocol and investigator oversight responsibilities. Dr. Hrozencik provided a statement indicating no plans to participate in future research. The observations on the Form 483 necessitate a formal response to address these deficiencies in clinical trial conduct and record management.