Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...

The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide ...

In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...

AICA currently supports auditing against 21 CFR Parts 11, 211, and 600, each mapped at the section and subsection levels.

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 ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...