FDA 483 - Zenflow, Inc. - October 30, 2025

Zenflow, Inc. in South San Francisco, CA, a manufacturer of nitinol spring implants, was cited for significant quality system deficiencies during an FDA inspection. The observations highlight failures in validating critical test methods, establishing adequate supplier management procedures, documenting design input requirements, implementing corrective and preventive actions, and conducting thorough risk analyses. These issues collectively pose potential risks to patient safety and device reliability.