FDA 483 - The See Clear Company - May 24, 2022

The See Clear Company, a specification developer of contact lens devices in Peachtree Corners, GA, received five observations during an FDA inspection. The firm was cited for significant deficiencies in its quality system, including a lack of established procedures for design transfer, quality audits, and management review. Additionally, inadequate documentation for CAPA activities and change records were noted, with some issues being repeat observations from prior inspections.