FDA 483 - CLER VISION INC - February 20, 2025

CLER VISION INC, a contract manufacturer of rigid contact lenses in Riverside, CA, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in process validation documentation, corrective and preventive action procedures, complaint handling, and supplier approval processes. These issues included a server breach that impacted quality records and a failure to follow established procedures for various quality system elements.