FDA 483 - Sovereign Pharmaceuticals, LLC - May 12, 2025

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 adequately validate manufacturing and packaging processes, thoroughly investigate out-of-specification results, and ensure scientifically sound test procedures and complete raw material testing. These issues indicate a systemic breakdown in quality assurance and compliance with good manufacturing practices.