Our FDA inspection readiness audits replicate real inspection conditions, assessing GMP compliance, data integrity, training records, and quality systems. We help pharmaceutical companies address regulatory gaps and improve their chances of passing U.S. FDA inspections successfully.
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...
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...
