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 19, 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In March 2026, the FDA released new draft guidance outlining its expectations for responding to Form 483 observations. This webinar breaks down that guidance and translates it into practical, actionable steps for developing clear, complete, and effective responses.

Attendees will gain a clear understanding of FDA expectations, common response pitfalls, and proven strategies for addressing inspectional findings. You will learn how to build CAPAs that are not only complete, but defensible and aligned with regulatory expectations.

Highlights Include:

• 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.