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

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 ...

Some staff members say they are frustrated with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The official in charge of federal food and drug safety ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

Dr Reddy's Laboratories receives US FDA Form 483 with five observations at Srikakulam facility; company to address issues ...

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 ...

Generic drugmaker Granules India’s Hyderabad-based pharmaceutical formulation intermediates and finished dosages manufacturing subsidiary Granules Life Sciences (GLS) has received establishment ...

Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...

At the same time, Food Safety and Inspection Service (FSIS) food recalls fell by 60.0 percent to just six events, down from ...

Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson’s fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this ...

His departure comes at a time of many concerns within the agency, including staff frustrations with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The ...