Importing seafood into the United States carries specific responsibilities under FDA’s Seafood HACCP regulations. Firms importing fish and fishery products must comply with 21 CFR 123.12 and establish appropriate verification procedures to demonstrate seafood import compliance.
This webinar explores the history and legal basis of GRAS, compares GRAS to alternative regulatory pathways, and reviews FDA notification and self-determined GRAS approaches. The presentation also discusses the role of qualified experts in establishing GRAS conclusions, species-specific safety considerations, and regulatory challenges associated with novel animal food ingredients.
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.
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 In 2026, the FDA released new draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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.
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.