Newport Medical Instruments, Costa Mesa, CA, Feb. 21 (Irvine, CA).(MEDICAL DEVICES)

The manufacturer of ventilators was determined to be not in compliance with current GMPs of the Quality Systems regulation.

First, the firm failed to establish and maintain plans that define the responsibility for implementation of design and development activities and failure to review, update, and approve the plans as the design development evolves.

For example, the responsibilities of the project team leader and members involved in the design project of one type of ventilator were not clearly described in the DHF.

Next, the company did not establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

Specifically, the firm did not establish written procedures for changes made during product development; and establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.

Further, FDA wrote about failure to verify the device design to confirm that the design output meets the design input requirements. For example, there were no built history records in the DHF for prototypes used for various engineering tests and verifications during the design project of one type of ventilator.

Also cited was the failure to establish and maintain procedures for quality audits. For example, the areas for design controls and device tracking were not covered in the Au gust 2006 internal quality audit.

Next was failure to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality.

For example, workstations where the firm processed components and assemblies were not inspected and tested for surface and ground resistances on a timely basis.

In addition, FDA stated that the company did not establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. There was no documentation of calibration dates for measurement equipment in the QC room, the agency wrote. Cal; Design; QC/QS; E-M; Val; Doc. 14108W

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