Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know

Presented by Lisa El-Shall and Jeb Hunter

May 8, 2026 | 2:00 PM ET

When the FDA issues a Form 483 at the conclusion of a drug CGMP inspection, your response becomes a defining regulatory moment. How you address these observations can directly influence outcomes, including the risk of Warning Letters or further enforcement action.

In March 2026, the FDA released new draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” This webinar will include a focused review of that guidance, breaking down key expectations and what they mean for industry.

In addition to reviewing the draft guidance, our experts will provide practical recommendations for developing clear, complete, and effective responses to Form 483 observations. Attendees will gain insight into FDA expectations, common response pitfalls, and proven strategies for addressing inspectional findings, including the development of corrective and preventive actions (CAPAs) that are both effective and defensible.

This session is designed to help companies align their response strategies with FDA’s latest thinking while strengthening overall inspection readiness.

Highlights Include:

• Review of FDA Draft Guidance (March 2026): key expectations and takeaways from “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”
• Submitting an Effective Response: format and content, interim updates, submission timelines, and where to send responses
• Addressing 483 Observations: interpreting findings, establishing management responsibility, and developing robust CAPA plans with demonstrated effectiveness
• Managing Disagreements with FDA: when and how to respond, and best practices for maintaining a constructive dialogue

Who Should Attend:

• Quality and Compliance Professionals
• Regulatory Affairs Teams
• Pharmaceutical Manufacturing Leadership
• Internal Audit and Inspection Readiness Teams

Ensure your next 483 response is thorough, defensible, and aligned with FDA expectations

About the Presenters

Lisa El-Shall

Senior Director for Pharmaceutical and Device Consulting Services

Lisa El-Shall has a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and quality. For the past 11 years she led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including development, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.

Jeb Hunter

Senior Regulatory Consultant

Jeb S. Hunter holds a BS in Microbiology from Clemson University and has spent his career in Quality, starting in a microbiology and chemistry laboratory setting and moving into auditing and managing Quality Management Systems. Jeb has experience in the Pharmaceutical, Medical Device, Dietary Supplement, and Food/Tobacco industries. He is a highly capable team auditor and Lead Auditor across auditing platforms with audits conducted against a host of regulatory standards both domestic and international.