Devices

Multiple Avertix Medical Violations Cited

David McFarland

— 1 min read
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A 2/19-3/11/2025 FDA inspection at Avertix Medical in Eatontown, NJ, found multiple violations in the firm’s manufacture of The Guardian System, an implantable coronary syndrome event detector. A just-released nine-page 9/3/2025 Warning Letter lists these Quality System Regulation violations:

  • failure to maintain complaint files and failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  • failure to adequately establish and maintain procedures to control product that does not conform to specified requirements;
  • failure to adequately establish and maintain procedures for validating the device design, including adequate risk analysis;
  • failure to adequately establish and maintain procedures for implementing corrective and preventive action;
  • failure to validate with a high degree of assurance and approve according to established procedures a process whose results cannot be fully verified by subsequent inspection and test; and
  • failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.

The letter lists these Medical Device Reporting violations:

  • failure to report to FDA information required by regulations no later than 30 days after the day the firm received or otherwise became aware of information from any source reasonably suggesting that a device the firm markets may have caused or contributed to a death or serious injury; and
  • failure to report to FDA information required by regulations within 30 days of receiving or becoming aware of information from any source that reasonably suggests that a marketed device had malfunctioned and that device or a similar device that the firm markets would be likely to cause or contribute to death or serious injury if the malfunction were to recur.

The letter lists this Correction and Removal violation:

  • failure to submit a required report to FDA within 10 days of initiating a correction or removal.

Avertix was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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