FDA 483 - Alejandro (NMI) Hoberman, M.D. - June 18, 2024

An FDA inspection of Alejandro (NMI) Hoberman, M.D., a clinical investigator facility in Pittsburgh, PA, was conducted from June 12 to June 18, 2024. The inspection identified a significant observation concerning the general requirements for informed consent, as stipulated by federal regulations. Specifically, the FDA noted that for a particular protocol, the informed consent information was not presented in a language understandable to the subject's representative. An instance was cited where a Spanish-speaking parent, acting as the representative for a child, signed an English version of the consent form on July 23, 2021. Although reconsent was later obtained using a Spanish-translated form on February 2, 2022, the initial process was non-compliant. This observation highlights a critical issue in ensuring that study participants or their legal representatives fully comprehend the details of a study before providing consent. While the FDA 483 document serves as an observation report and does not explicitly list required actions, such findings necessitate a comprehensive review of informed consent procedures, implementation of robust language accessibility protocols, and the development of appropriate corrective and preventive actions to ensure full compliance with human subject protection regulations and the Federal Food, Drug, and Cosmetic Act.