# FDA 483 - Fluke Biomedical LLC - November 21, 2022

Source: https://www.keypedia.com/records/483/fluke-biomedical-llc/02d74220-87f6-407d-8c7c-fbc75c09d0be

> FDA 483 for Fluke Biomedical LLC on November 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fluke Biomedical LLC
- Inspection Date: 2022-11-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Fluke Health Solutions, Inc. in Everett, WA, a manufacturer of medical devices, received a Form FDA 483 with 15 observations following an inspection from November 7-21, 2022. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, CAPA, non-conforming product control, design controls, purchasing, and training. These issues indicate a systemic lack of adherence to established quality system regulations for medical device manufacturing.

## Related Documents

- [483 - 2024-01-18](https://www.keypedia.com/records/483/fluke-biomedical-llc/044e7180-9a7f-4119-b55f-88e1765c32f7)

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

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