Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.

Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...

DexCom (DXCM) does not expect a material impact from the FDA’s warning letter to its manufacturing capacity or its fiscal year 2025 guidance ...

Dexcom said the warning letter, which the FDA has yet to publish, describes non-conformities in the manufacturing processes and quality management systems at the two facilities. The company does ...

The company said the letter from the Food and Drug Administration (FDA) noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators.

A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...