# FDA 483 - Fluke Biomedical LLC - January 18, 2024

Source: https://www.keypedia.com/records/483/fluke-biomedical-llc/044e7180-9a7f-4119-b55f-88e1765c32f7

> FDA 483 for Fluke Biomedical LLC on January 18, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fluke Biomedical LLC
- Inspection Date: 2024-01-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Fluke Biomedical LLC in Everett, WA, identified two significant observations. The firm failed to adequately establish and implement corrective and preventive action procedures, leading to incomplete field action determinations and unaddressed complaints. Additionally, the company lacked documented justifications for not reporting certain correction or removal actions to the FDA.

## Related Documents

- [483 - 2022-11-21](https://www.keypedia.com/records/483/fluke-biomedical-llc/02d74220-87f6-407d-8c7c-fbc75c09d0be)

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)
- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/fluke-biomedical-llc/70d6902b-4b77-4efb-92de-34ebe4e2ef01

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