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

Alejandro (NMI) Hoberman, M.D., a clinical investigator in Pittsburgh, PA, was cited for a single observation during an FDA inspection from June 12-18, 2024. The observation detailed a failure to meet general informed consent requirements, specifically that a parent fluent only in Spanish signed an English consent form for their child. Reconsent was subsequently obtained using a Spanish translated version of the consent form.