Sovereign Pharmaceuticals, LLC – FDA 483, Aug 2, 2023

Sovereign Pharmaceuticals, LLC in Fort Worth, TX, was inspected and cited for significant deficiencies in its quality control unit, laboratory controls, and component testing. The firm failed to properly document deviations and rejected lots during process validation, lacked scientific justification for analytical methods and deviations from test procedures, and did not perform all required tests for incoming raw materials. These issues indicate a lack of robust quality systems and control over drug product manufacturing and testing.