FDA 483 - Donna S. Hrozencik, M.D. - January 26, 2022

This FDA Form 483 report details significant deficiencies at Donna S. Hrozencik, M.D., a clinical investigator site in Canton, MI, following an inspection from January 13-26, 2022. The inspection revealed multiple failures in conducting an investigational study, including inadequate IRB reporting and approval, non-adherence to the investigational plan, poor record-keeping, and insufficient record retention. These issues indicate a concerning lack of oversight and compliance with regulatory requirements for human subject protection and data integrity.