FDA 483 - SALUS MEDICAL LLC - October 24, 2024
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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.
ID · 56388b44-2081-4870-9b51-1b7aa84baf5d