IntroductionAn FDA Inspection Readiness Audit is a proactive evaluation of your facility, documentation, and quality systems—designed to uncover potential issues before regulators do. It simulates a real FDA inspection and...

IntroductionAn unexpected FDA inspection can either validate your compliance efforts—or expose costly gaps. Being prepared is not just about documentation; it’s about building a culture of continuous compliance across your...

The FDA inspection readiness audit is a critical process for organizations in regulated industries, such as pharmaceuticals, medical devices, and food production. It ensures compliance with FDA regulations, identifies gaps...