FDA 483 - Sovereign Pharmaceuticals, LLC - September 01, 2021

An FDA inspection of Sovereign Pharmaceuticals, LLC, a contract manufacturer in Fort Worth, TX, revealed significant deficiencies across its quality system, laboratory controls, and production records. The firm failed to follow its own quality unit procedures, lacked adequate written procedures for data reprocessing and microbial identification, and released drug products from a failed blend uniformity lot. Additionally, master production records were found to be incomplete, omitting a routine manufacturing step.