Responding to Food and Seafood FDA 483s

Presented by Mark Moen and Jeb Hunter

May 19, 2026 | 2:00 PM ET

When the FDA issues a Form 483 or Warning Letter, your response is critical—and time-sensitive. How you respond can directly impact regulatory outcomes, enforcement risk, and your firm’s credibility.

This webinar will walk through FDA expectations for responding to inspectional observations, along with proven strategies for developing clear, complete, and effective responses. Attendees will gain practical guidance on crafting responses that not only address findings, but also demonstrate control, accountability, and a path to sustained compliance.

Key topics include:

• Building a complete response – Ensure each observation is fully addressed with appropriate detail and supporting documentation
• Corrective & preventive actions (CAPA) – Clearly communicate what has been done and what is planned to prevent recurrence
• Setting realistic timelines – Avoid overpromising while maintaining credibility with FDA
• Ongoing FDA communication – Best practices for follow-up, updates, and maintaining a constructive dialogue

About the Presenters

Mark Moen

Senior Regulatory Consultant

Mark Moen has spent over 25 years in the Seafood and Food Industry, from his beginning as a Sea Sampler for the International Pacific Halibut Commission during the summer months of college years at Washington State University. He went onto work at all levels in the Seafood Industry, and joined FDA as a CSO, and spent several years doing Seafood HACCP, LACF, AF, Food and worked at the FDA Prior Notice Center. He then went on to work for various Seafood and Food firms as a Quality Director or Quality Assurance Manager and moved onto his own Consulting firm the last few years, working with small to medium size firms assisting them with their Food Safety concerns.

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.