FDA 483 - Ausberto B. Hidalgo, M.D. - December 03, 2021

Ausberto B. Hidalgo, M.D. in Pembroke Pines, FL, was inspected by the FDA from 11/29/2021 to 12/3/2021 as a Clinical Investigator. The inspection revealed significant issues with adherence to the investigational plan, including missing test results and inadequate documentation for subject inclusion criteria. Additionally, the firm failed to report study protocol deviations to the Institutional Review Board (IRB) prior to implementing changes in research activity.