FDA 483 - CYNDRX LLC - December 18, 2025

An FDA inspection of CYNDRX LLC in Brentwood, TN, a specification developer, identified one significant observation related to inadequate design transfer procedures. The firm failed to establish documents ensuring that design control activities for its CyndRx AbsorbaSeal 5.6.7.F Vascular Closure Device were correctly translated into production specifications. This indicates a procedural lapse in ensuring product quality and regulatory compliance.