# FDA 483 - SALUS MEDICAL LLC - October 24, 2024

Source: https://www.keypedia.com/records/483/salus-medical-llc/56388b44-2081-4870-9b51-1b7aa84baf5d

> FDA 483 for SALUS MEDICAL LLC on October 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SALUS MEDICAL LLC
- Inspection Date: 2024-10-24
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2019-05-16](https://www.keypedia.com/records/483/salus-medical-llc/c7967cc2-f807-4704-98be-9ba03a39df50)

## Related Officers

- [investigator](https://www.keypedia.com/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)

Company: https://www.keypedia.com/companies/salus-medical-llc/c5663cac-19ae-4ade-b131-20a3e429fb27

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face