FDA 483 - Infrared Laboratories, LLC - April 01, 2024

Infrared Laboratories, LLC in Westfield, IN, was inspected by the FDA from March 25 to April 1, 2024. The inspection revealed a significant deficiency in the firm's design control procedures, specifically concerning the establishment and documentation of design outputs. This indicates a failure to adequately define and verify product design, which is a critical aspect of quality system compliance for manufacturers.