FDA 483 - SMITHWORKS, INC. - April 04, 2025

SMITHWORKS, INC. in Lindale, TX, a medical device manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish procedures for design changes, specifically regarding the validation of testing procedure modifications for IV Fluid Warmers. Additionally, they lacked proper procedures for controlling nonconforming products, including review, segregation, disposition, and ensuring sufficient data for investigations and corrective actions.