FDA 483 - Shape Memory Medical, Incorporation - March 13, 2025

Shape Memory Medical, Incorporation in San Jose, CA, received a Form 483 for inadequate procedures related to receiving, reviewing, and evaluating complaints for its Class 2 IMPEDE FX device. The inspection found that the firm's complaint handling procedure failed to provide sufficient guidance on managing investigations, documenting investigator actions, and ensuring timely processing and escalation of complaints. Multiple complaints were closed outside of established timelines without proper documentation or escalation.