FDA 483 - Jersey Dental Supplies - May 29, 2025

Jersey Dental Supplies LLC, a distributor of Class I and II dental medical devices, was cited for significant deficiencies in its quality system. The firm failed to establish fundamental quality procedures for areas like internal audits, CAPA, and training, with some issues being repeat observations. Additionally, management review procedures were inadequate, lacking documented reviews since 2012 and proper approval.