DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter | Global News Avenue

Dexcom shares (DXCM) On Monday, the glucose monitoring equipment manufacturer reported that it had received a warning letter from federal regulators about the condition of its two manufacturing plants.

The company said Food and Drug Administration (FDA) The “defects in response” from dexcom to FDA Form 483 are pointed out, and the researchers’ observations are outlined.

The company noted that the FDA inspected its San Diego, California and Mesa, Arizona, last year, and the facility found “failure and quality management systems in the manufacturing process.”

Dexcom explained that it has “had submitted some responses to Form 483 and is preparing a written response to the warning letter.” It added that it plans to “continue to take certain corrections and corrective actions”, although there is no guarantee that the FDA will be satisfied with the response set by the deadline regulator.

Dexcom says warning letters are not expected to have any significant impact

The company noted that its operations were not affected and did not have any significant impact from the warning letter.

In addition, Dexcom announced that it has appointed Renée Galá to the board of directors. Gala is currently the president and chief operating officer of Jazz Pharmaceuticals (jazz).

Dexcom shares have lost 45% of its value over the past year.