Working With FDA: Practical Insights from a Former FDA Official
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About This Session
Navigating interactions with the FDA can feel complex, high-stakes, and often uncertain for food and beverage manufacturers. In this FSMA Friday session, Don Kautter of The Acheson Group (TAG), a former FDA official with deep experience in inspections, compliance, and regulatory policy, offers clear, practical guidance to help companies engage confidently and effectively with the Agency.
This session will unpack what FDA investigators look for, how to prepare for inspections, and the behaviors and documentation that build trust and credibility. Don will also share real-world insights on responding to FDA inquiries, managing follow-up actions, and avoiding common pitfalls that can escalate compliance risk.
Meet the Speaker
Don Kautter, Senior Advisor at The Acheson Group
Donald A. Kautter, Jr. (Don) is a nationally recognized expert in food safety, regulatory compliance, and enforcement, with over 30 years of high-impact leadership at the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA).
Donald A. Kautter, Jr. (Don) is a nationally recognized expert in food safety, regulatory compliance, and enforcement, with over 30 years of high-impact leadership at the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA).
As Senior Advisor and Consumer Safety Officer at FDA’s Center for Food Safety and Applied Nutrition (now Human Foods Program), Don was the senior regulatory and scientific authority on complex microbial contamination, environmental monitoring, intentional adulteration, and FSMA Preventive Controls for Human Food. He provided decisive technical guidance and was the agency’s leading expert on critical enforcement actions, including warning letters, recalls, injunctions, suspensions, and compliance directives, ensuring that agency decisions were legally sound, scientifically justified, and effectively mitigate public health risks.
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