Inspections

Medical device manufacturer reports conclusion of FDA inspection

Published in Medical Letter on the CDC and FDA, April 4th, 2004

On February 11, Utah Medical Products, Inc., (UTMD) publicly disclosed a comprehensive inspection of its Utah facility by three U.S. Food and Drug Administration (FDA) inspectors from Minneapolis, Dallas, and Denver, which began on February 2.

In response to shareholder questions regarding the status of the inspection, UTMD announces that on March 3, the inspection ended with the presentation of seven observations in a Form FDA-483, which the company reviewed completely with the inspectors.

These observations relate to only 6 of more than 150 subsections of the FDA Quality System Regulation (QSR). UTMD is now preparing a written response to the FDA...

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