FDA 483 - Jose C. Pinero, M.D. - October 09, 2025

An FDA inspection of Jose C. Pinero, M.D., a clinical investigator in Coral Gables, FL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included a failure to adhere to the investigational plan regarding participant randomization and consent timing, as well as a failure to maintain adequate and accurate case histories, lacking original and contemporaneous records for participant consent and symptom documentation.