Master FDA Import Compliance Today!
Complimentary Webinar Series!
Sept. 9 – FDA Detained My Product – Now What?
Sept. 16 – What Do I Need to Know About My Testing Lab?
Sept. 23 – How Do I Get Removed From an FDA Red List?
Sept. 30 – How Do I Prevent Getting on an FDA Red List?
Register now using the form!
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.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
Master FDA Import Compliance
Complimentary Webinar Series!
Sept. 9 – FDA Detained My Product – Now What?
Sept. 16 – What Do I Need to Know About My Testing Lab?
Sept. 23 – How Do I Get Removed From an FDA Red List?
Sept. 30 – How Do I Prevent Getting on an FDA Red List?
Register now using the form!
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.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
Master FDA Import Compliance
Webinar Schedule
Every Tuesday in September, starting Sept. 9.
Register for any or all sessions using the form!
FDA Detained My Product – Now What?
Tuesday, Sept. 9, 2025 | 1:00 PM ET
- Understand why FDA detentions occur and the regulatory basis behind them.
- Learn how to break down and interpret an FDA Notice of Action.
- Gain step-by-step guidance on resolving a detention efficiently.
- Discover how to read and leverage an Import Alert to your advantage.
- Explore proactive steps you can take now to minimize risk and streamline compliance.
- Get clear, actionable answers to common questions about FDA detentions.
What Do I Need to Know About My Testing Lab?
Tuesday, Sept. 16, 2025 | 1:00 PM ET
- Understand FDA import requirements for chemical contaminants, residues, and labeling compliance. How are methods validated and matrices extended?
- Learn testing strategies for pesticides, heavy metals, mycotoxins, melamine, chloramphenicol, nitrofurans, aflatoxins, etc.
- See how advanced techniques like HPLC-MS/MS and GC-MS improve detection and accuracy. What are the Limits of Detection (LOD) and Limit of Quantitation (LOQ) requirements?
- Get practical guidance on sampling, method selection, and interpreting results for regulatory success.
- Discover proactive approaches to prevent costly detentions, refusals, and recalls at the border.
How Do I Get Removed From an FDA Red List?
Tuesday, Sept. 23, 2025 | 1:00 PM ET
- Understand why companies become subject to Detention Without Physical Examination (DWPE).
- Learn the types of evidence required to demonstrate resolution of violations.
- Explore scenarios that may require multiple clean shipments or an FDA inspection.
- Review the role of corrective and preventive action plans in addressing violations.
- Recognize how updating a Food Safety Plan fits into the DWPE removal process.
- See what’s involved in compiling evidence and submitting a petition to the FDA for review.
How Do I Prevent Getting on an FDA Red List?
Tuesday, Sept. 30, 2025 | 1:00 PM ET
- 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.
Meet Our 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.
Maged Sharaf, Ph.D.
Senior Director for Labeling, Cannabis, and Claims Consulting Services, EAS Consulting Group
Dr. Maged Sharaf specializes in FDA and FTC compliance, including label reviews, claims substantiation, 21 CFR 111 audits, and support for dietary supplements, cosmetics, and cannabis. An expert in botanical sciences and regulations, Dr. Sharaf has extensive experience guiding clients through product detentions, NDI submissions, and safety-focused compliance strategies.
He holds a Ph.D. in Pharmaceutical Sciences from the University of Pittsburgh and is a recognized authority in 21 CFR 111 and 21 CFR 117. Dr. Sharaf has served with the U.S. Pharmacopeia since 2015, contributing to standards in nomenclature, labeling, and dietary supplements. He is also active with the American Herbal Pharmacopeia, the American Botanical Council, and the HPTLC Association.
Prior to consulting, he held leadership roles at CAMAG Scientific, the American Herbal Products Association, and the U.S. Pharmacopeia, where he advanced standards for foods, dietary supplements, and herbal medicines.
Jay F. Alappat, Ph.D.
Chief Science Officer – Chemistry
Certified Group
Dr. Jay F. Alappat is an innovative analytical chemist with more than 20 years of experience in method development, validation, and implementation for food quality, safety, and sustainability. He serves as the Chief Science Officer – Chemistry at Certified Group, leading scientific strategy, technical innovation, and business growth initiatives across North America.
Dr. Alappat is internationally recognized for developing and validating advanced methods for allergen, contaminant, and nutritional analysis, including the implementation of next-generation technologies such as PCR and HPLC-MS. He has played a pivotal role in expanding laboratory capabilities, optimizing facilities, and ensuring compliance with FDA, USDA, and international regulatory standards.
Dr. Alappat holds a Ph.D. in Analytical Chemistry, with postdoctoral specialization in natural products and molecular biology. He is an accomplished author of peer-reviewed research and industry guidelines and is passionate about elevating the standards of food safety, quality, and sustainability in a rapidly evolving global market.
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.
About Certified Group
Certified Group partners with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.