FDA 483 - DESIGN CATAPULT MANUFACTURING, INC. - August 19, 2025

DESIGN CATAPULT MANUFACTURING, INC., a contract manufacturer, was cited for inadequate documentation of corrective and preventive action activities. The firm failed to document investigation activities used to determine the cause of nonconformities, specifically lacking records for the 5 Why Method investigations. This indicates a deficiency in their quality system documentation practices.