DexCom received a warning letter from the Food and Drug Administration ... noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators.

Dexcom has received a warning letter from the FDA, after the agency uncovered issues ... official list of observations, known as a Form 483. According to the agency, some of those findings ...

SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities ...

March 7 (Reuters) - Medical device maker Dexcom (DXCM.O), opens new tab said it has received a warning ... A Form 483 is a type of agency report containing "observations" that FDA inspectors ...

In the warning letter, the FDA cited deficiencies in the response letters sent by the company to the FDA following the Form 483, List of Investigational Observations, which was delivered to the ...

The warning letter did not identify any new observations that had not already been provided in the Form 483s previously issued to the company by the FDA at the conclusion of its two inspections in ...

The FDA cited deficiencies in the company ... as well as shortcomings in its responses to prior Form 483 observations. However, the warning letter does not restrict DexCom’s ability to ...