FDA 483 - Frank A. Sinicrope, M.D., Clinical Investigator - February 26, 2021

An FDA inspection of Frank A. Sinicrope, M.D., Clinical Investigator in Rochester, MN, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to adhere to the investigational plan and protocol, improper documentation of informed consent, and inadequate maintenance of case histories and physical exam data. These issues indicate a lack of control over critical aspects of clinical trial conduct and subject protection.