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 ...

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, ...

The Food and Drug Administration is inspecting far fewer pharmaceutical companies conducting clinical research as it adjusts to the post-pandemic world and a smaller workforce, which an auditor warned ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...

An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...

Amid concerns about FDA’s capacity to meet safety mandates following the departure of 3,500 employee since January, the agency signals a new direction for inspections and ability to do more with less ...

In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...

WASHINGTON (AP) — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory ...

WASHINGTON — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections ...