Dexcom receives FDA warning letter for two manufacturing sites
The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and ...
Frozen mac and cheese bites have been recalled. Here's where they were sold in Arizona
Frozen mac and cheese bites were sold at grocers in Arizona and across the U.S. Here's what we know and what to do if you ...
MedTech Dive5d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
WolverinesWire18d
Why Kyrsten Sinema wants Arizona to lead the way on researching a West African plant
Kyrsten Sinema returned to where her political career began: the Arizona House. She touted the benefits of ibogaine to treat military brain injuries.
FOX 10 Phoenix2d
RFK Jr. seeks to eliminate FDA’s GRAS 'loophole' to improve food ingredient safety
The Health and Human Services secretary is pushing to change a program that allows companies to add untested ingredients to food.
Medical Device Network on MSN3d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenue
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Drug Delivery Business4d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
Newsweek20d
Ice Cream Recall Update As FDA Issues Highest Risk Warning
Arizona Foods Group Inc ... All of the involved product was subsequently destroyed." The FDA says on its website regarding food allergies: "Symptoms of food allergies typically appear from ...
DexCom receives warning letter from FDA, sees no impact to FY25 guidance
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
Yahoo Finance7d
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be ... and at its manufacturing facilities in Mesa, Arizona and Penang, Malaysia, according to a ...