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5 GMP Compliance Lessons from 2025's FDA Warning Letters

See where quality systems are breaking down—and how to strengthen yours before regulators arrive

When the FDA issues a warning letter, it's a signal to the entire industry about where compliance is failing. Our analysis of 85 drug product warning letters posted in 2025 reveals the patterns: supplier qualification gaps, quality units without real authority, validation programs that stopped at Stage 2, and data integrity failures that suggest deeper cultural problems.

Most striking? The FDA recommended external GMP consultation in 87% of cases—a clear sign that internal self-correction had already failed.

This white paper translates warning letter data into actionable lessons drawn from our consultants' firsthand remediation experience.

Download the guide to learn:

• The top 21 CFR Part 211 sections driving warning letters—and what they reveal about systemic weaknesses
• Why supplier qualification is likely your biggest unaddressed vulnerability
• How to tell if your quality unit has functional authority, not just documented authority
• What regional data integrity disparities tell us about compliance culture
• Why waiting for regulatory action to seek an external perspective is already too late
• Six self-assessment questions to pressure-test your own systems today

The companies that avoid warning letters aren't lucky—they're proactive. Get the guide and find out where your gaps are hiding. ⤵️