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 ...

A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...

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

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...

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 | ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following inspections of its two key manufacturing facilities, sending its shares down ...

Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...

After rising to prominence during the COVID-19 pandemic, South African drugmaker Aspen Pharmacare has landed in the FDA's ...

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

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 ...