FDA 483 - Angel Medical Systems, Inc. - March 11, 2025

Avertix Medical, Inc. received a Form FDA 483 with 10 observations highlighting significant deficiencies in its quality system for The Guardian System, an implantable cardiac monitoring device. The firm failed to adequately establish procedures for complaint handling, corrective and preventive actions, nonconforming product control, and medical device reporting. Additionally, issues were noted with sterilization validation, recall reporting timeliness, supplier management, and Unique Device Identification database submissions.