FDA 483 - Sovereign Pharmaceuticals, LLC - April 22, 2022

Sovereign Pharmaceuticals, LLC, a contract manufacturer in Fort Worth, TX, was cited for significant deficiencies across its quality system, including inadequate written procedures, untimely quality control investigations, and failure to follow complaint handling procedures. Repeat observations highlight issues with uninvestigated validation failures and insufficient laboratory controls, indicating a systemic lack of adherence to established protocols. These issues collectively demonstrate a failure to ensure product quality and compliance with regulatory requirements.