# FDA 483 - Modus Health, LLC - May 10, 2023

Source: https://www.keypedia.com/records/483/modus-health-llc/2d8385b5-c36f-48e3-92e8-a5c5768b5f07

> FDA 483 for Modus Health, LLC on May 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Modus Health, LLC
- Inspection Date: 2023-05-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Modus Health, LLC in Edmonds, WA was inspected from May 9-10, 2023, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's procedures for controlling non-conforming products and for establishing adequate corrective and preventive actions. These issues indicate a need for improved quality system controls.

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/modus-health-llc/56cd1d17-aa5a-4dff-8471-ea6ae353d45d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822