The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
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 have them in your freezer.
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
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 ...
Arizona, and Wisconsin. According to the FDA, the recall is still ongoing. The FDA officially classified it as Class II on March 4. Botulism poisoning is rare. According to the FDA, there are ...
The recalled product could contain metal objects in the food, according to the FDA. Rare virus that killed Gene Hackman's wife surged in Arizona in 2024 Arizona will warm up briefly for the ...
LAWRENCE, Ks. (AP) — Hunter Dickinson matched a career high with 33 points to lead Kansas past No. 24 Arizona 83-76 on Saturday. Zeke Mayo drilled five three-pointers and had 20 points while KJ ...