FDA 483 - Specialty Vision Llc - December 19, 2024

An FDA inspection of Specialty Vision llc in Ridgefield Park, NJ, a dealer/retailer of contact lenses, revealed significant deficiencies in its quality system. The firm failed to establish essential procedures for its quality system, including management responsibility, supplier control, CAPA, and complaint handling. Additionally, acceptance activities for incoming products were not documented, and procedures for the rework of nonconforming products were not adequately established.