Years after warning from FDA, Nephron sees ‘egregious’ violations in inspection

The company based in Lexington County received its inspection report back from federal regulators. Here’s what it showed.
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FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews.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 ...

Is Your Medication Made in a Contaminated Factory? The FDA Won’t Tell You

The agency’s decision to conceal drug names on inspection reports has prevented doctors, pharmacists and patients from ...
ConsumerAffairs

FDA increases warning about listeria-tainted pasta meals

The U.S. Food & Drug Administration has confirmed that the multistate outbreak of Listeriosis linked to refrigerated and ...

Alvotech: Initiating With Hold Rating On FDA CRL AVT05 And Reduced EBITDA Guidance

Alvotech rated Hold after FDA setback for AVT05. Click for my look at ALVO stock prospects and what would make me upgrade it ...

Atorvastatin recall may affect hundreds of thousands of patients – and reflects FDA’s troubles inspecting medicines manufactured overseas

This recall affects America’s most prescribed drug. It’s the latest in a series of concerning manufacturing issues that have ...
BioSpace

Pharmas Hope FDA PreCheck Can Help Avoid Facility-Related Drug Rejections

Executives from Eli Lilly, Merck and other companies foresee the FDA's new onshoring proposal being anything from a ...
Fierce Pharma

Birds, lizards and cats, oh my: FDA blasts generic drug maker Hetero in scathing Form 483

The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...
JD Supra

Risks vs Benefits: Applying the REF Rule in FDA Recalls

The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S.