FDA 483 - The See Clear Company - November 22, 2019

The Lee Clear Company, a specification developer of contact lenses in Peachtree Corners, GA, was cited for significant quality system deficiencies. The inspection revealed issues with design control, including deviations from the 510K and contract manufacturer's design, inadequate control over suppliers, and undocumented corrective actions. Additionally, the firm lacked adequate procedures for complaint handling and medical device reporting, and failed to document quality audits and personnel training, with the latter two being repeated observations.