FDA WARNING_LETTER - Avertix Medical, Inc. - March 11, 2025

The FDA issued a Warning Letter to Avertix Medical, Inc. following an inspection from February 19 to March 11, 2025, concerning their manufacture of The Guardian System, an implantable coronary syndrome event detector. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, specifically regarding Quality System Regulation (21 CFR Part 820), Medical Device Reporting (21 CFR Part 803), and Reports of Corrections and Removals (21 CFR Part 806). Key violations included failure to maintain adequate complaint files, untimely complaint processing, and insufficient investigations into device failures. The firm also failed to establish proper procedures for controlling nonconforming products and adequately validating device design, including reassessing risks based on post-market data like infection and battery failure rates. Further issues involved non-adherence to Corrective and Preventive Action procedures, lack of sterilization process validation, and incomplete implementation of supplier management. Additionally, Avertix Medical, Inc. failed to timely report serious injuries and device malfunctions to the FDA and lacked adequate written Medical Device Reporting procedures. The company also neglected to submit a required report of correction or removal within 10 working days after advising physicians about premature battery depletion in their implantable devices. The FDA deemed the company"s responses inadequate, noting that many corrective actions were in-progress or lacked sufficient detail. Avertix Medical, Inc. is required to take prompt action to address all violations, submitting a comprehensive written response within fifteen business days detailing corrective actions, prevention strategies, supporting documentation, and a timeline for completion to avoid further regulatory measures.