AICA currently supports auditing against 21 CFR Parts 11, 211, and 600, each mapped at the section and subsection levels. Additional regulations, including 21 CFR Parts 50, 54, 56, 58, 312, 314, and ...
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 ...
Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
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 ...
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 move, ...
This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. The U.S. Food and Drug Administration took ...
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