FDA EIR - Olga M. Lapeyra, M.D. - October 25, 2021

An FDA inspection of Olga M. Lapeyra, M.D., a clinical investigator in Miami Lakes, FL, was conducted from October 12 to October 25, 2021. This pre-announced, high-priority inspection, requested by the Center for Drug Evaluation and Research, assessed compliance with Bioresearch Monitoring standards for clinical investigators, under a specific Investigational New Drug (IND) application.

The inspection revealed two significant observations cited on an FDA Form 483. These included a failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation, and a failure to conduct the investigation in accordance with the investigational plan. Key issues discussed included missing protocol-required tests for three subjects, incorrect investigational product dosing for one randomized subject, inaccurate transcription of concomitant medications for four subjects, and unblinded study personnel performing tasks assigned to blinded staff. Additionally, there were instances of positive urine drug screens not adequately documented or discussed, and a subject not being re-consented with an updated informed consent form.

These findings highlight non-adherence to regulatory requirements concerning data integrity, protocol adherence, and subject protection. Dr. Lapeyra acknowledged the observations and discussed plans for staff retraining, improved source documentation practices, and clearer role definitions for unblinded personnel. She was advised to provide a written response to the FDA Form 483 within 15 business days, and received a verbal warning regarding potential regulatory actions for violations of the Food, Drug & Cosmetic Act.