FDA 483 - McKeon Products, Inc. - May 07, 2025

McKeon Products, Inc. in Warren, MI, a medical device establishment, was cited with three observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the lack of written Medical Device Reporting (MDR) procedures, inadequate complaint handling processes, and poorly established corrective and preventive action (CAPA) procedures. These issues indicate a systemic failure to maintain proper quality controls and regulatory compliance.