FDA 483 - Menicon America, Inc. - December 19, 2024

During an FDA inspection from December 17-19, 2024, Menicon America, Inc. in North Billerica, MA, was cited for inadequate corrective and preventive action (CAPA) procedures. The firm's CAPA system failed to ensure that corrective actions were verified for effectiveness and did not properly document extensions for overdue CAPAs. This indicates a significant deficiency in their quality system for manufacturing.