FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
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, ...
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. 1 This announcement applies to ...
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 ...
While the FDA’s inspection figures for drug manufacturing facilities have yet to fully recover from the COVID-19 pandemic, sweeping staff cuts have raised questions about how the agency plans to ...
The company based in Lexington County received its inspection report back from federal regulators. Here's what it showed.
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