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