FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...

Intas Pharmaceuticals’ new warning letter from the U.S. FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. The FDA handed Intas a ...

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and ...

Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into opportunities.

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...

An FDA inspection of a Tom’s of Maine manufacturing facility led to the discovery of “significant violations,” including bacteria in water used to make toothpaste and a black “mold-like” substance.

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

For years, U.S. pharmaceutical companies have relied on drugs produced overseas to meet Americans' medical needs. And for years, it's been clear that federal drug regulators couldn't keep up with ...

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...