FDA EIR - Nader Iskander, M.D. - August 06, 2021

An FDA inspection of Nader Iskander, M.D., also known as San Antonio Eye Specialists in San Antonio, TX, occurred from August 2-6, 2021. This high-priority inspection, conducted under Compliance Program 7348.811 for Clinical Investigators, aimed to verify allegations from a complaint regarding an Investigational New Drug (IND) study regulated by 21 CFR Parts 50, 56, and 312. The inspection confirmed the allegations, noting the sponsor had already terminated the site due to numerous noncompliance issues. The FDA issued a two-item Form FDA-483, citing key violations. Firstly, the investigation was not conducted according to the signed investigator statement and plan, specifically due to the use of incorrect measurement scales for patient assessments and the enrollment of subjects who did not meet inclusion or exclusion criteria. The report highlighted that clinical coordinators, rather than the investigator, improperly determined subject eligibility. Secondly, the site failed to obtain adequate informed consent, utilizing an outdated version of the consent form for all subjects instead of the most current IRB-approved version. Dr. Iskander was advised of his responsibility for ensuring protocol compliance and proper staff qualification. He committed to providing a written response within 15 days, with the FDA indicating potential legal sanctions, including a warning letter or disqualification, if adequate corrective actions are not implemented.