FDA 483 - Bradshaw Medical, Inc. - September 12, 2025

An FDA inspection of Bradshaw Medical, Inc. in Kenosha, WI, a medical device manufacturer, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control of nonconforming products, and routine equipment maintenance. These issues indicate a lack of robust controls necessary for ensuring product quality and compliance with regulatory requirements.