FDA 483 - Sol-Millennium Medical Inc. - May 08, 2025

An FDA inspection of Sol-Millennium Medical Inc. in Chicago, IL, revealed significant deficiencies in their medical device reporting (MDR) and corrective and preventive action (CAPA) systems. The firm failed to submit complete initial MDRs and timely supplemental MDRs, and their CAPA procedures were inadequate, failing to address root causes or previous violations. These issues indicate a systemic lack of compliance in handling complaints and ensuring product quality for medication delivery devices.