Orion Medical Solutions, LLC – FDA 483, May 21, 2026

Orion Medical Solutions, LLC, an initial importer and complaint file establishment in Watkinsville, GA, was cited for multiple deficiencies in its quality management system during an FDA inspection. The observations primarily concern inadequate written procedures for complaint handling, corrective actions, document control, and traceability, as well as a lack of quality agreements with suppliers and proper purchasing controls for Class III pre-filled syringe products. These issues indicate a systemic lack of documented and implemented controls essential for medical device quality.