The FDA has flagged three third-party labs that submitted device testing data that may have falsified, invalid or copied from ...

WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food ...

The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new ...

The Food and Drug Administration has not met its mandated targets for domestic and international food safety inspections since 2018, according to a Government Accountability Office report released ...

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 ...

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 inspections ...

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...

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 ...

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 ...

Glenmark Pharmaceuticals has received a Form 483 with six observations following a US FDA GMP inspection of its Goa ...