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

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

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 ...

Drugmaker Glenmark Pharmaceuticals’ formulations manufacturing facility in Chhatrapati Sambhajinagar, Maharashtra, has completed an inspection by the U.S. Food and Drug Administration.

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

The FDA continues to face significant staffing shortages in its drug inspection workforce, according to a new report from the Government Accountability Office. Despite some progress in resuming ...

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 ...

Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

The FDA’s lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time ...

The FDA is preparing to scale back on routine drug inspections following widespread layoffs in support staff, multiple officials told CBS News. Around 170 employees were cut from the FDA’s Office of ...