FDA 483 - MX IMAGING, INC. - April 26, 2023

MX IMAGING, INC., a medical device manufacturer in Torrance, CA, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the maintenance of both Device History Records and Device Master Records for their CFP 1515 product. These issues indicate a lack of proper documentation for device manufacturing, specifications, and quality assurance.