FDA 483 - Specialty Vision Llc - July 07, 2022

An FDA inspection of Specialty Vision llc in Ridgefield Park, NJ, a dealer/retailer in contact lenses, revealed significant deficiencies in its quality system. The firm lacked established procedures for critical operations, failed to document acceptance of incoming products, and conducted uncontrolled rework of nonconforming items. These issues indicate a fundamental lack of control over product quality and compliance.