We value your privacy
We use cookies to analyze site traffic and improve your experience. See our Privacy Policy.
Clinical Trials
0
0 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
- 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.
