Nephron SC, Inc.

FDA Finds 'Egregious' Manufacturing Violations at Nephron Pharmaceuticals Despite Years of Warnings

- FDA inspectors found six major violations at Nephron Pharmaceuticals in August 2025, including lack of written procedures to prevent contamination and deficient environmental monitoring systems. - The company has failed to address recurring sterility issues despite receiving three FDA warning letters since 2020 and voluntarily recalling over 2 million drug doses in 2022. - Regulatory experts warn that repeated violations could lead to facility shutdown or consent decree, as the FDA has ongoing compliance activities with the South Carolina-based manufacturer. - Nephron has issued 20 product recalls since 2012 and received complaints about contaminated medications, including reports of fruity odors and dark particles in sterile products.