FDA 483 - Roger S. Keresztes, M.D. - September 27, 2019

An FDA inspection of Roger S. Keresztes, M.D. in Stony Brook, NY, a clinical investigator, revealed significant deviations from good clinical practice. The firm failed to conduct investigations in accordance with the investigational plan, enrolling subjects who did not meet eligibility criteria or lacked required pre-enrollment testing. Additionally, the inspection found failures in obtaining informed consent prior to study procedures and maintaining complete case histories, indicating serious issues with human subject protection and data integrity.