FDA 483 - Hummayun Ismail, M.D. - August 01, 2025

The FDA conducted an inspection of Hummayun Ismail, M.D. and Delaware Medical Care Associates LLC in Newark, DE, from July 22 to August 1, 2025. This inspection resulted in an FDA Form 483, detailing several observations regarding non-compliance with clinical investigation regulations.

Primary issues included inadequate and inaccurate case histories. For instance, investigational product was administered to subjects prior to documented dispensation in the Interactive Response Technology (IRT) system, and significant discrepancies were found between subject source records and pharmacy dispensing logs regarding administration times. Another key observation was the insufficient documentation of investigational drug disposition; specifically, unused study drug lacked a properly signed certificate of destruction. Furthermore, the investigation was not conducted in adherence to the established investigational plan, particularly concerning informed consent. Observations noted that an Investigator did not obtain informed consent for all enrolled subjects, and several actively participating subjects failed to sign the most current version of the informed consent form.

These observations, issued under the Federal Food, Drug and Cosmetic Act, require Hummayun Ismail, M.D. and Delaware Medical Care Associates LLC to implement prompt corrective and preventative actions. Addressing these findings is crucial to ensure data integrity, maintain proper accountability for investigational products, and uphold ethical standards in clinical trial conduct.