FDA 483 - Fluke Biomedical LLC - November 21, 2022

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.