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

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.