FDA 483 - Luminopia Inc - May 02, 2025

An FDA inspection of Luminopia Inc. in Cambridge, MA, from April 30 to May 2, 2025, revealed a significant quality system deficiency. The firm failed to maintain device history records for its Luminopia SaMD product and lacked a documented procedure for them, despite having distributed over (b)(4) units. This indicates a fundamental breakdown in documenting the production process for a medical device.