# FDA 483 - SALUS MEDICAL LLC - May 16, 2019

Source: https://www.keypedia.com/records/483/salus-medical-llc/c7967cc2-f807-4704-98be-9ba03a39df50

> FDA 483 for SALUS MEDICAL LLC on May 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SALUS MEDICAL LLC
- Inspection Date: 2019-05-16
- Product Type: drugs
- Office Name: Denver District Office
- Summary: SAIUS MEDICAL LLC, a packer/repacker in Phoenix, AZ, was inspected by the FDA from May 13-16, 2019. The inspection revealed significant deficiencies in written procedures for labeling, quality control, complaint handling, training, and product storage conditions. These issues indicate a lack of adequate controls to ensure the identity, strength, quality, and purity of drug products.

## Related Documents

- [483 - 2024-10-24](https://www.keypedia.com/records/483/salus-medical-llc/56388b44-2081-4870-9b51-1b7aa84baf5d)

## Related Officers

- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

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