3-D Matrix, Inc. – FDA 483, Nov 17, 2021

3-D Matrix, Inc. in Newton, MA, a medical device manufacturer, was cited with six observations during an FDA inspection. Deficiencies included a lack of established acceptance criteria for validation activities, failure to report a device removal involving a potential risk to health, inadequate corrective and preventive action procedures, and insufficient control over non-conforming products. Additionally, the firm failed to maintain proper records of changes and lacked written Medical Device Reporting (MDR) procedures for adverse events.