FDA 483 - Northern Digital Inc. - August 28, 2025

Northern Digital Inc., a manufacturer of Class II Reflective Marker Spheres in Waterloo, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate complaint handling and Medical Device Reporting (MDR) procedures, insufficient supplier control for contract manufacturers and sterilizers, and a lack of personnel familiarity with key FDA regulations. These issues indicate a systemic failure to ensure compliance for devices intended for the US market.