Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...
DXCM faces an FDA warning over manufacturing issues, but operations remain unaffected. However, supply-chain risks and rising ...
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
DexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024. The FDA cited deficiencies in the company’s manufacturing ...
Dexcom, a medical device manufacturer that develops continuous glucose monitoring systems, received a warning letter from the FDA regarding manufacturing processes at its facilities in San Diego and ...
Novo Nordisk’s weight loss drug Wegovy is linked to an increased risk of hair loss, a study suggests. Meanwhile, Dexcom ...
Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...
The agency is advising people to avoid misusing or inhaling the products that are marketed as whipped cream chargers but have ...
Most of the patients in these reported cases experienced anaphylaxis within 1 hour after injection. Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and ...