FDA 483 - MPM Medical LLC - April 17, 2026

MPM Medical LLC, an initial importer of medical devices in Mesquite, TX, received two observations during an FDA inspection. The firm was cited for inadequately documenting its risk management processes for product preservation, especially concerning its role as an initial importer. Additionally, the firm failed to adequately establish and implement verification activities to ensure purchased sterile medical devices meet specified requirements, lacking proper documentation in incoming inspection records.