FDA Import Success Series | Mastering Compliance at Every Step
How Do I Prevent Getting on an FDA Red List?
Session 4 of 4
Presented by Tim Lombardo and Annie Hughes
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
- Learn why compliance with FDA and USDA regulations is the only way to avoid FDA import alerts.
- Understand the key food safety regulations that apply, including 21 CFR 117 for human food and 21 CFR 507 for animal food.
- Review requirements ensuring each food ingredient is permissible in the U.S.
- Recognize the importance of FDA-compliant labeling for imported products.
- See how FDA addresses adulterated foods and the role of a robust food safety or HACCP plan in mitigating hazards.
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About the Presenters
Annie Hughes
Key Account Executive, Certified Group
Annie Hughes brings over 13 years of specialized experience navigating the complex landscapes of food safety, import compliance, and international trade within the food and beverage industries. She is a trusted authority for importers facing FDA detention.
As a Key Account Executive at Certified Group, she bridges the gap between regulatory hurdles and actionable solutions, empowering food and beverage importers to overcome compliance challenges.
Her extensive background in food testing gives her an understanding of both the technical and financial challenges confronting the industry. She provides practical, revenue-preserving solutions.
Annie’s academic foundation, with BS and MS degrees in Agricultural Economics from the University of Florida, complements her ability to address the financial, logistical, and regulatory pain points of importers. She has served as a subject matter expert at several import industry events.
Tim Lombardo
Senior Director for Food Consulting Services, EAS Consulting Group
Tim Lombardo is a recognized expert in food safety and microbiology with over 25 years of experience in dairy, infant formula, baked goods, nuts, produce, meat and poultry, spices, flavors, and other ingredients. He is a Lead Instructor through the Food Safety and Preventive Controls Alliance (FSPCA) for Human and Animal Foods, certified in Thermal/Aseptic Processing and Sterilization through the Better Process Control School, and a Lead Instructor for the HACCP Controls Alliance.
Before joining EAS, he was Lead Staff Scientist at Eurofins, overseeing microbiological investigations and Food Safety Plan development. He also spent 17 years at Leprino Foods Company, culminating as Corporate Manager of Sanitation, providing leadership to 10 facilities, including three producing infant formula ingredients, and managing GMPs, HACCP, Environmental Monitoring, Pest Control, Traceability, and Ingredient Monitoring programs.
A published author and international speaker, Tim is a member of IFT, IAFP, and the U.S. Hemp Authority Technical Committee, and is a combat veteran of Operation Desert Shield and Desert Storm.
Posted in Foods, On Demand Webinar.