# FDA 483 - Burke, Inc. - August 13, 2021

Source: https://www.keypedia.com/records/483/burke-inc/0c81e1fb-e8a7-46f3-9f3d-1cccdd616333

> FDA 483 for Burke, Inc. on August 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Burke, Inc.
- Inspection Date: 2021-08-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Burke, Inc. in Kansas City, KS, a manufacturer of medical devices, was inspected by the FDA from August 9-13, 2021. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for finished device acceptance, design change control, non-conforming product control, and purchasing controls. These issues indicate a lack of robust quality management practices for their Class II and Class I medical devices, such as powered wheelchairs and bariatric beds.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)
- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/burke-inc/209dd7de-9732-4f0f-8329-bb09f4a8c19f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8