FDA 483 - Adolfo A. Cueli MD - March 05, 2020

An FDA inspection of Adolfo Cueli MD, a clinical investigator in Doral, FL, revealed significant deviations from investigational plans. The firm failed to conduct studies according to protocol, specifically regarding the processing and storage of pharmacokinetics (PK) samples and the adequate documentation of investigational product administration. These findings indicate a lack of adherence to critical study procedures.