FDA 483 - MEDIA PLUS, LLC - March 10, 2023

An FDA inspection of MEDIA PLUS, LLC in Englewood Cliffs, NJ, a specification developer and complaint file establishment, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures and documentation for design control, supplier management, and device history records for their SilverPro Pain Relief System. Additionally, the inspection found a lack of documented management reviews and unperformed quality audits, indicating a systemic breakdown in quality assurance processes.