483
Jose C. Pinero, M.D.Jose C. Pinero, M.D. – FDA 483, Oct 9, 2025
Record Details
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.
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