Pro-Optics LLC – FDA 483, Mar 11, 2026

An FDA inspection of Pro-Optics LLC in Palatine, IL, a manufacturer of Class II contact lens cases, revealed significant deficiencies across its quality management system. The firm failed to establish and maintain adequate design controls, including documentation for design changes and transfer, and did not maintain essential design output records. Additionally, Pro-Optics LLC did not properly control changes to its manufacturing processes or adequately evaluate and approve contract manufacturers, posing a substantial risk to device quality.