2026-05-04 FDA Warning Letter: Naseem A. Jaffrani, M.D. Cited for Clinical Investigator
Letter issued · posted to fda.gov .
Subject as published: Clinical Investigator
TL;DR
In short: FDA issued a Warning Letter to Naseem A. Jaffrani, M.D. on 2026-05-04 citing: Clinical Investigator. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naseem-jaffrani-md-729750-05042026
Argus analysis
Naseem A. Jaffrani, M.D. (MARCS-CMS 729750) received an FDA Warning Letter dated May 4, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Clinical Investigator. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 19, 2026.
Clinical Investigator letters cite 21 CFR Part 312 (Investigational New Drug Application) and the FDA's Good Clinical Practice (GCP) framework. Typical findings include failure to follow the investigational plan, inadequate recordkeeping of drug disposition, or failure to obtain proper informed consent — findings FDA can escalate to disqualification proceedings under 21 CFR 312.70 if uncorrected.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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 re…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Naseem A. Jaffrani, M.D. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Naseem A. Jaffrani, M.D. as of 2026-05-19. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-05-04 FDA Warning Letter: Naseem A. Jaffrani, M.D. Cited for Clinical Investigator. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-naseem-a-jaffrani-m-d-2026-05-04-warning-letter
"2026-05-04 FDA Warning Letter: Naseem A. Jaffrani, M.D. Cited for Clinical Investigator." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-naseem-a-jaffrani-m-d-2026-05-04-warning-letter.
Argus HQ Research. "2026-05-04 FDA Warning Letter: Naseem A. Jaffrani, M.D. Cited for Clinical Investigator." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-naseem-a-jaffrani-m-d-2026-05-04-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_naseem_a_jaffrani_m_d_2026_05_04_warning_letter_2026,
title = {2026-05-04 FDA Warning Letter: Naseem A. Jaffrani, M.D. Cited for Clinical Investigator},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-naseem-a-jaffrani-m-d-2026-05-04-warning-letter},
note = {Accessed: July 13, 2026}
}