Naseem A. Jaffrani, M.D. — FDA Warning Letter, May 4, 2026: Clinical Investigator

FDA Warning Letter — Violations FDA cited at Naseem A. Jaffrani, M.D.

WARNING LETTER Naseem A. Jaffrani, M.D. MARCS-CMS 729750 — May 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-05-01 Product: Drugs Recipient: Naseem A. Jaffrani, M.D. 3311 Prescott Road, Suite 310 Alexandria , LA 71301 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-05-01 Dear Dr. Jaffrani: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between February 24 and March 13, 2025. The investigator representing FDA reviewed your conduct of the following clinical investigations: Protocol (b)(4) , “ (b)(4) ,” of the investigational drug (b)(4) , performed for (b)(4) Protocol (b)(4) , “ (b)(4) ,” of the investigational drug (b)(4) , performed for (b)(4) This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your March 31, 2025, written response to the Form FDA 483. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated March 31, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following: You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60]. As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plans for Protocol (b)(4) and Protocol (b)(4) required you to report all serious adverse events (SAEs) to the sponsor within 24 hours of your knowledge of the occurrence. You failed to adhere to this requirement. Specifically: 1. The investigational plan for Protocol (b)(4) required every SAE, regardless of causality, occurring after the subject has provided informed consent and until 16 weeks after the last dose of study drug, to be reported to (b)(4) safety team immediately, without undue delay, but under no circumstances later than 24 hours after your learning about the events 1 . Specifically, Subject (b)(6) was consented on July 6, 2020, and the last dose of study drug occurred on July 8, 2024. This subject experienced the following SAEs, which were not reported to the sponsor’s safety team within the required time frame: a. The subject experienced an SAE of non-ST elevation myocardial infarction (NSTEMI) between September 1 and 3, 2022, which you became aware of on September 2, 2022. However, this SAE was not initially reported to the sponsor’s safety team until September 26, 2022. b. The subject experienced SAEs of COVID-19 pneumonia, chronic obstructive pulmonary disease exacerbation, and hospitalization for congestive heart failure between January 5 and 9, 2023, which you became aware of on January 5, 2023. However, these SAEs were not initially reported to the sponsor’s safety team until February 21, 2023; April 3, 2023; and May 1, 2023, respectively. c. The subject experienced SAEs of pulmonary embolism and deep vein thrombosis post-COVID-19 pneumonia between January 13 and 17, 2023, which you became aware of on January 13, 2023. However, these SAEs were not initially reported to the sponsor’s safety team until May 1, 2023. d. The