There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...

WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the ...

The slivered onions supplier used dirty equipment that led to cross-contamination, the FDA said, and employees failed to meet ...

Food safety experts explain why there have been so many food recalls lately, plus how to stay on top of the latest news ...

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...

In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities ...

The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...

The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...

Mississippi lawmakers are considering House Bill 602 and Senate Bill 2014, both designed to ensure consumers know whether ...