FDA WARNING_LETTER - Naseem A. Jaffrani, M.D. - March 13, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Naseem A. Jaffrani, M.D., following an inspection of his clinical site conducted between February 24 and March 13, 2025. The inspection assessed Dr. Jaffrani’s performance as a clinical investigator for two specific drug protocols. The agency concluded that Dr. Jaffrani failed to adhere to the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (21 CFR Part 312), which govern clinical research and the protection of human subjects.

The primary violation identified was the failure to follow the investigational plan, specifically regarding the reporting of serious adverse events (SAEs). Protocol requirements mandated that the investigator report all SAEs to the sponsor within 24 hours of discovery. However, the FDA documented multiple instances where reporting was delayed by weeks or even months. These events included life-threatening conditions such as myocardial infarction, pulmonary embolism, and congestive heart failure.

In his initial response, Dr. Jaffrani admitted to relying too heavily on research coordinators without sufficient oversight. While he proposed training and a new notification system, the FDA found his response inadequate due to a lack of detail regarding how he would supervise delegated tasks to ensure compliance. Dr. Jaffrani is required to provide a detailed corrective action plan within 15 business days to address these deficiencies and prevent future violations.