FDA EIR - Wissam Abouzgheib, MD - January 29, 2018

An FDA inspection of Clinical Investigator Wissam Abouzgheib, MD, in Camden, NJ, was conducted from January 25-29, 2018. The inspection, carried out under CPG 7348.811, assessed compliance with applicable regulations and protocol adherence for a medical device study. A Form FDA-483, Inspectional Observations, was issued, citing a primary violation related to 21 CFR 812.100. Specifically, the investigation was not conducted according to the signed agreement because a subject (ORA13_01_005) who met an exclusion criterion—having a specific medical condition—was improperly included in the study and received the investigational device.

Management discussions revealed further issues, including a Sub Investigator being delegated tasks without appropriate education or experience for the study's focus, missing original signed protocol pages for certain versions, and an inaccurate monitoring log. Additionally, records for study device accountability were incomplete, lacking disposition information for returned devices. Dr. Abouzgheib acknowledged the findings and committed to providing a formal response to the FDA-483 within 15 business days, along with improving record-keeping and ensuring stricter adherence to study protocols.