Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

DexCom DXCM is facing regulatory scrutiny following a warning letter recently posted by the FDA. This could affect the ...

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

The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities.

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...

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Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous glucose monitor maker’s facilities last year. In a filing with the ...

With its active pharmaceutical ingredient (API) facility “in a state of disrepair,” manufacturer Aspen Biopharma Labs’ operations have ground to a halt in the U.S., according to a recent FDA reprim | ...