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March 25, 2014
08:41 EDTDXCMDexCom receives FDA warning letter for administrative deficiencies
DexCom announced that it has received a warning letter from the U.S. Food & Drug Administration resulting from a November 2013 inspection of the company’s facility in San Diego, California by the FDA’s Los Angeles District Office. The warning letter relates to deficiencies in filing medical device reports involving the company’s continuous glucose monitoring system. Regulations related to MDR reporting were updated by the FDA in July 2013, and during the inspection, the FDA determined that the company was not compliant with these recent updates. There were, however, no sanctions levied by the FDA, nor does the warning letter impact the company’s ability to manufacture and sell its G4 Platinum systems and sensors. Furthermore, the warning letter does not affect any of the company’s pending or future submissions for product approvals. Before the end of April, DexCom expects to submit all materials necessary to demonstrate to the FDA’s satisfaction that the company is in compliance with its reporting obligations in an effort to resolve any remaining deficiencies and close out the warning letter in due course.
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