Visionary Contact Lens, Inc. – FDA 483, Nov 10, 2021

Visionary Contact Lens, Inc. in Anaheim, CA, a manufacturer of gas permeable contact lenses, was cited for significant quality system deficiencies during an FDA inspection. Observations included a lack of defined supplier control procedures, inadequate documentation of corrective and preventive action effectiveness plans, and undocumented process validation activities. The lack of documented process validation was noted as a repeat observation.