FDA 483 - 3-D Matrix, Inc. - October 18, 2023

An FDA inspection of 3-D Matrix, Inc. in Newton, MA, revealed significant quality system deficiencies across multiple areas. The firm failed to adequately establish procedures for corrective and preventive actions, process validation, product handling, non-conforming product control, complaint handling, equipment calibration, and supplier evaluation. These issues indicate a systemic breakdown in maintaining quality and regulatory compliance for their PuraGel and PuraStat devices.