483
CLER VISION INCCLER VISION INC – FDA 483, Feb 20, 2025
Record Details
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.
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