FDA Issues Warning Letter for Administrative Deficiency to Diabetes-Monitor MakerMonday, March 31, 2014
San Diego diabetes monitor maker DexCom Inc. has received a warning letter from the Food and Drug Administration following a November 2013 inspection of the company’s building.
The FDA found deficiencies in DexCom’s (Nasdaq: DXTM) filing of medical device reports, which were not up to speed with recent updates in the FDA’s policy. The FDA didn’t levy any sanctions against DexCom, and its warning letter won’t affect the manufacture of the company’s products or future product approvals.
DexCom expects to update its paperwork by the end of April.