DXCM faces an FDA warning over manufacturing issues, but operations remain unaffected. However, supply-chain risks and rising ...
The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and ...
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Cheng Xin / Getty Images DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants. The maker of glucose monitoring devices said ...
Two years ago, Eli Lilly started working with Dexcom to integrate continuous glucose monitoring (CGM) into its insulin delivery devices, and it has now firmed up the alliance. Lilly has taken a ...
The company does not expect the warning letter to materially impact its manufacturing capacity or sales, and it can continue to make and sell devices ... review of Dexcom’s 15-day sensor to ...