IEH Academy Webinar

Navigating FDA’s Import Alerts vs. Import Certification

Importing FDA-regulated products requires navigating a complex web of Customs and FDA regulations to minimize disruptions to trade flow and keep shipments moving efficiently to their intended destination. Two of the most misunderstood regulatory tools are FDA Import Alerts (Detention Without Physical Examination/DWPE) and Import Certification processes. An Import Alert serves as an enforcement red flag that automatically detains non-compliant shipments, while Import Certification acts as a prerequisite or safety verification mechanism under FSMA/FDA rules.

RSVP

Webinar Recording

Description

This webinar breaks down the core distinctions between Import Alerts and Import Certification, examines how each impacts your supply chain, and provides a clear, actionable roadmap for petitioning for removal from Import Alerts and fulfilling or seeking exemptions from Import Certification requirements.

Benefits and Learning Objectives:

Distinguish between an FDA Import Alert (Red/Green List enforcement process) and mandatory Import Certification frameworks.
Learn the exact, evidence-based steps required to petition FDA’s Division of Import Operations (DIO) for removal from the Import Alert Red List.
Implement rigorous root-cause analysis and Corrective and Preventive Action (CAPA) plans that satisfy FDA reviewers.
Understand the technical requirements, testing protocols, and documentation needed for five consecutive compliant entries.
Discover available opt-outs, exemptions, and compliance strategies within FSVP and Import Certification guidance to maintain trade continuity.

Agenda:

Introduction & Regulatory Context

FDA border oversight tools: OASIS, SERIO, PREDICT, and port inspections.
Import Alerts (DWPE) vs. Import Certification requirements.

FDA Import Alerts

Common triggers: microbiological, chemical, labeling, and FSVP non-compliance.
Red, Green, and Yellow Lists.
DWPE impacts: demurrage, testing, and supply chain delays.

Import Certification & FSVP Compliance

Accredited Third-Party Certification and Qualified Individuals (QIs).
Overlap between supplier verification (FSVP) and Import Certification.
Exemptions, opt-outs, and applicable guidance.

Strategies for Addressing Import Alerts & Certification Issues

Import Alerts
- Root-cause investigations, CAPAs, five clean commercial entries, and DIO removal petitions.
Import Certification Issues
- Audits, accredited recertification, and FDA registrations and filings.

Common Pitfalls & Petition Rejections

Sample collection errors, incomplete CAPAs, and premature petitions.

Who Should Attend:

Food, beverage, cosmetic, and medical device Importers of Record (IORs)
Foreign manufacturers and export managers shipping to the U.S. market
Regulatory affairs, quality assurance, and food safety executives
Licensed customs brokers and logistics/supply chain directors
Legal counsel specializing in FDA and international trade compliance

Webinar Length

1 hour with Q&A to follow.

The webinar will include a 10-minute Q&A session where attendees can ask questions related to the Navigating FDA’s Import Alerts vs. Import Certification. This interactive portion is designed to offer personalized guidance and facilitate the sharing of practical insights among participants.

RSVP

Meet the Instructor

Dan Solis

Mr. Dan Solis joined IEH as Vice President of Technical Services in 2026. He earned his M.S. in Healthcare Administration from the University of La Verne and B.S. from the University of California, Irvine.

Before joining IEH, Mr. Solis spent nearly three decades at the U.S. Food and Drug Administration (FDA), most recently serving as Assistant Commissioner for Import Operations. Throughout his FDA career, he held numerous leadership positions, including Acting Director of the Office of Enforcement and Import Operations, Division Director for West Coast Imports, and Director of Import Operations for the Los Angeles District. Earlier in his career, he served as a Consumer Safety Officer at FDA headquarters, Import Compliance Officer in the Los Angeles District, and Microbiologist at the FDA’s Irvine, California laboratory.

Throughout his career at FDA, Mr. Solis led several national initiatives, including implementation of the FDA Imports Shield Program, Import Certification Portal, and nationwide rollout of the PREDICT system across U.S. ports. He also established joint FDA and U.S. Customs and Border Protection teams, including the Opioid Task Force, created the West Coast Import Advisory Council, and worked with major trade groups on paperless transaction initiatives.

Mr. Solis is a nationally recognized subject matter expert in import operations and border security and has served as a national instructor on import investigations. He also held advisory roles on the FSMA Foreign Supplier Verification Program (FSVP) Implementation Team, the Associate Commissioner’s IT Advisory Workgroup, and the Associate Commissioner’s Import Advisory Panel.

Let's get in touch

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