FDA EIR - Diaz, Leslie, M.D. - March 08, 2011

An FDA inspection of Leslie E. Diaz, M.D., operating as Infectious Disease Associates of the Palm Beaches, was conducted from January 12 to March 8, 2011. This unannounced for-cause inspection, initiated due to a complaint and conducted under regulatory framework CP 7348.811 and 21 CFR 312.60, focused on two clinical trials. The inspection revealed significant deficiencies in the conduct and oversight of these studies. Primary violations included a pervasive lack of source documentation, specifically regarding verification of subject inclusion/exclusion criteria, concomitant therapy, and comprehensive evaluation of adverse events and laboratory abnormalities. Laboratory assessments were not consistently performed according to protocol schedules, and a Serious Adverse Event was not reported timely to the sponsor or IRB. The inspection also identified missing subject records, incomplete Case Report Forms, and the use of outdated CRF versions. Furthermore, Dr. Diaz failed to submit continuing review reports or site closure reports to the IRBs and did not adhere to sponsor instructions for disposing of investigational drug supplies, resulting in incomplete drug accountability. Dr. Diaz acknowledged ultimate responsibility, admitted to poor recordkeeping and a lack of oversight. Consequently, a Form FDA-483 (Inspectional Observations) was issued. Dr. Diaz signed an affidavit detailing admissions and indicated her intent to submit a written response, stating she would not conduct future clinical trials.