FDA 483 - Pulmodyne Inc. - April 22, 2025

An FDA inspection of Pulmodyne Inc. in Indianapolis, IN, identified significant deficiencies in the firm's design control procedures. The company failed to adequately define design outputs, verify design outputs against input requirements, and validate the device's conformity to user needs under actual or simulated use conditions. These findings indicate a lack of robust design control, which is critical for ensuring device safety and effectiveness.