Devices

Quality System, Other Violations at 3B Medical

A 12/1-12/10/2025 FDA inspection at 3B Medical, doing business as Reach Health in Dublin, OH, found multiple violations in the firm’s manufacturing of iCodeConnect, a cloud-based software device used with continuous positive airway pressure and auto-adjusting positive airway pressure ventilator devices. A just-released 5/20 Warning Letter says the company also imports and provides complaint handling for two BMC Medical ventilator devices imported from China. The letter lists these Quality System Regulation violations:

failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner and complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA;
failure to establish and maintain procedures for implementing corrective and preventive action;
failure to establish and maintain adequate procedures for implementing corrective and preventive action, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, including using appropriate statistical methodology where necessary to detect recurring quality problems;
failure to establish and maintain procedures for validating the device design, including risk analysis; and
failure to establish and maintain procedures to ensure that all personnel are trained to adequately perform their assigned responsibilities.

The letter says the firm’s responses to the Quality System violations were inadequate or their adequacy could not be determined.

FDA also says 3B does not have an approved PMA for two of its auto-adjusting positive airway units. It further failed to submit a required report within 10 days of initiating a correction or removal of a device. The company’s response to that inspection observation was not adequate, it says.

3B was told 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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