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Responding to Food and Seafood FDA 483s

Responding to Food and Seafood FDA 483s

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.

Animal Food GRAS: Unpacking the Essentials

Animal Food GRAS: Unpacking the Essentials

Animal Food GRAS: Unpacking the Essentials Presented by Dr. Adam Orr and Tim Lombardo June 17, 2026 | 3:00 PM ET The U.S. is one of the most promising and expansive markets for innovative animal food ingredients. However, accessing the US requires knowledge about its...
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know

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

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 In 2026, the FDA released new draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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

Overview of the Coming National Drug Code Format Change

Overview of the Coming National Drug Code Format Change

Overview of the Coming National Drug Code Format Change Presented by Victoria Pankovich EAS Consulting Group is hosting a complimentary webinar, Overview of the Coming National Drug Code (NDC) Format Change. The FDA has finalized a rule establishing a uniform 12-digit...
Dietary Supplement Finished Product Testing and Specifications

Dietary Supplement Finished Product Testing and Specifications

The FDA requires that dietary supplement manufactures establish finished product specifications and test to ensure the specifications are met. However, the process of implementing this requirement is not always straightforward. What tests need to be included? Does every lot have to be tested? What if there is not a scientifically valid method available? This webinar will answer those questions and explain how to be compliant with the specification requirement for finished dietary supplement products.

Food Safety Foundation: Developing a Risk-Based Supplier Approval Program

Food Safety Foundation: Developing a Risk-Based Supplier Approval Program

In this webinar, we will review the components of a risk-based supplier approval program to include (1) conducting a risk assessment, (2) conducting supplier verification, (3) ensuring adequate and proper documentation, and (4) implementing continuous improvement. Additionally, we will review supplier approval program requirements of the FDA and USDA and how these regulations compare some common 3rd party certification audit standards.