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

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

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Record Details

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.

Company: Alejandro (NMI) Hoberman, M.D.
Inspection Date: June 18, 2024
Product Type: Drugs
Office: Philadelphia District Office
Person: Cynthia L. Rakestraw

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ID · 75d36ed3-9fec-45b2-bbe9-591be0e3fa52