RAPS

FDA: No plans yet to resume onsite GMP foreign inspections

An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 ...
AZ Central

FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...
RAPS

FDA Raises Concerns With Novartis in Clinical Inspection

As part of Novartis’ new drug application for its recently approved multiple sclerosis drug Mayzent (siponimod), the US Food and Drug Administration (FDA) questioned the drugmaker’s data practices ...
The Desert Sun

Industry Urged to Strengthen HACCP Training and FSVP Training Amid Declining USDA & FDA Inspection Capacity

LUNENBURG, NOVA SCOTIA, CANADA, February 19, 2026 /EINPresswire.com/ — Growing concerns continue to emerge regarding inspection capacity within the U.S. Food and ...