FDA 483 - Bradshaw Medical, Inc. - August 15, 2017

Bradshaw Medical, Inc. in Kenosha, WI, a medical device manufacturer, was cited for significant deficiencies across three observations during an FDA inspection. The firm failed to adequately establish procedures for design changes, corrective and preventive actions (CAPA), and complaint handling, leading to issues with product quality and regulatory compliance. These findings indicate a systemic breakdown in their quality management system.