Warning Letter — Adnan Dahdul, MD
The FDA issued a Warning Letter to Adnan Dahdul, MD, following an inspection by the Office of Compliance and Biologics Quality regarding clinical investigation practices.
This affects clinical investigators, clinical research coordinators, and sponsors involved in biologics-related clinical trials.
The issuance of a Warning Letter from the Office of Compliance and Biologics Quality suggests significant deviations from Good Clinical Practice (GCP) or investigational plan requirements. For regulatory and clinical operations professionals, this highlights the FDA's ongoing oversight of clinical investigator responsibilities and the potential for compliance actions if study protocols are not strictly followed.
Clinical investigators should conduct a comprehensive audit of all active study protocols to ensure strict adherence to investigational plans. Quality teams should verify that all required documentation and reporting procedures are being followed per regulatory requirements to avoid clinical hold or enforcement actions.
FDA Warning Letter issued to: Adnan Dahdul, MD. 03/12/2026 — Office of Compliance and Biologics Quality. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adnan-dahdul-md-719607-03122026
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