FDA 483 - Sovereign Pharmaceuticals, LLC - December 12, 2019

Sovereign Pharmaceuticals, LLC in Fort Worth, TX was inspected and cited for significant quality system deficiencies. The firm's Quality Assurance unit failed to follow its own procedures, leading to the release of mislabeled drug product and inadequate investigations into discrepancies and customer complaints. Additionally, batch production records lacked complete labeling control records and documentation of quality checks.