FDA 483 - Matia Robotics US, Inc. - May 24, 2023

Matia Robotics US, Inc. in Salt Lake City, UT, a medical device manufacturer, was cited for three observations during an FDA inspection. The firm failed to investigate device complaints, lacked documentation for incoming product acceptance, and did not conduct management reviews of the quality system at defined intervals. These issues indicate deficiencies in the firm's quality management and control processes.