The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...
The notice follows inspections of three Philips facilities that found failures to meet standards for reporting complaints and ...
Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could ...
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FDA hits Philips with warning over manufacturing site deficiencies
In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over ...
The company based in Lexington County received its inspection report back from federal regulators. Here’s what it showed.
The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S.
Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing ...
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 ...
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 ...
The Food and Drug Administration has advanced an investigation into one Salmonella outbreak and declared another one over.
If you take cholesterol-lowering drugs called statins, you may have noticed a flurry of news coverage since late October 2025 ...
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