The Food and Drug Administration is investigating a new outbreak of infections caused by Listeria monocytogenes. There are 28 ...

A federal report found the FDA is struggling to meet inspection targets at high-risk facilities. We look at why these checks ...

Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.

If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...

Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Pharmaceutical company Alkem Laboratories Ltd on Thursday (March 13) announced that the United States Food and Drug ...

A California company’s dried lily flowers have been recalled because they may contain undeclared sulfites, according to the U ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

Many critical functions of the food division of the Food and Drug Administration have been drastically slowed or entirely stopped since late ...