Reading 2025's FDA Warning Letters: The Patterns Reshaping Global Pharma

In 2025, the FDA issued 303 drug warning letters, a 59% increase from 190 in 2024. These numbers reflect more than regulatory activity—they reveal where FDA inspections are focusing and how compliance expectations are evolving. This webinar examines the patterns emerging from 2025 warning letters, translating enforcement trends into practical insights that pharmaceutical manufacturers can use to strengthen inspection readiness.

Rather than reviewing individual warning letters, this 60-minute practitioner-led session analyses them as a compliance roadmap. Attendees will gain a clearer understanding of the recurring deficiencies identified by the FDA, the increasing emphasis on data integrity and documentation practices, and how these findings can help identify potential compliance gaps before an inspection.

What You Will Learn

• Why the sharp increase in FDA warning letters matters for pharmaceutical manufacturers.

• Key compliance patterns identified across 2025 warning letters.

• Data integrity trends, including why approximately 15% of all FY 2025 warning letters referenced data integrity findings and why that figure increased to 60% for Indian manufacturing sites.

• Common inspection observations, including identity testing deficiencies, record integrity concerns and documentation issues.

• Insights into the FDA's first warning letter citing the misuse of AI in CGMP documentation.

• Practical approaches to evaluating your own site's compliance based on real regulatory findings rather than theoretical guidance.

Who Should Attend

This webinar is designed for:

• Quality Assurance Heads

• Data Integrity Leads

• Compliance Officers

• IT Operations Teams

• CSV and Digital Quality Professionals

• Regulatory Affairs Professionals

• Manufacturing and Testing Site Leaders

• Professionals responsible for inspection readiness, particularly at facilities exporting pharmaceutical products to the United States.

Webinar Format

• Duration: 60 Minutes

• Format: Live practitioner-led discussion

• Approach: Data-driven, practical and focused on real FDA inspection trends rather than vendor-led presentations.

Featured Speakers

• Dr. Sumedha Nadkar – Pharmaceutical Strategy & Technology Consultant

• Dr. Paritosh Singh – Sr. Scientist (Formulation R&D), Perrigo Company PLC