FDA 483 - SALUS MEDICAL LLC - October 24, 2024

SALUS MEDICAL LLC, a repacker in Phoenix, AZ, was cited for significant deficiencies in its quality management system, including a lack of a quality unit and essential procedures for complaint handling, adverse events, product review, and change controls. This inspection also revealed a failure to follow warehousing procedures, specifically regarding the documentation of drug product storage conditions and temperature logs for an extended period. One observation was noted as recurring, indicating persistent issues.