JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Northwest Arkansas Democrat Gazette

FDA’s inspections still lag pre-pandemic period

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 ...
Agri-Pulse

Shifting FDA food safety inspection to states has big challenges

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, ...
Fast Company

FDA drug-plant inspections still haven’t recovered from the pandemic, AP reports

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 ...
FiercePharma

FDA slams Intas, Ipca over manufacturing shortfalls at 3 Indian plants

After a pandemic-fueled lull the past few years, FDA inspections are back in full force. This week, a pair of Indian drugmakers have found themselves in the agency’s crosshairs. The FDA has handed ...

Recent FDA inspection reveals Nephron hasn't fixed consistent issues for years

The company based in Lexington County received its inspection report back from federal regulators. Here's what it showed.
Food

GAO and senators slam FDA food inspection shortfalls

FDA is under fire for missing its mandated food safety inspection goals every year since 2018 and for reducing funds for state and local food safety programs The Government Accountability Office ...