FDA Import Alert (DWPE) &
Red List Removal Assistance
LMG guides manufacturers through the FDA import alert removal process — from root cause analysis and laboratory testing to ITACS uploads and the formal removal petition.
What Is FDA DWPE & the Red List?
Understanding the mechanism before starting the removal process.
Detention Without Physical Examination
When FDA places a firm or product on an import alert, every subsequent shipment from that firm is automatically detained at every US port of entry — without individual examination. US Customs and Border Protection flags the shipment based on the importer, exporter, or product description matching the import alert database. The shipment cannot enter US commerce until either the specific entry is released by the local FDA district office, or the firm is formally removed from the import alert.
The FDA Import Alert Database
The FDA maintains a publicly searchable import alert database — informally called the Red List — that records every firm and product subject to DWPE by import alert number, country of origin, product category, and violation charge. Import alerts cover all FDA-regulated products: food, dietary supplements, drugs, medical devices, and cosmetics. Being listed affects every shipment from your facility to the United States, regardless of which port it arrives at.
Our Import Alert Removal Services
Import alert removal is a formal regulatory process. A well-documented, properly structured submission makes the strongest possible case with FDA.
Import Alert Review & Root Cause Analysis
We identify the exact import alert number and charge applicable to your firm, product, or country of origin. We then work with your team to determine the root cause of the violation — whether labeling, product composition, microbiological contamination, pesticide residues, heavy metals, GMP deficiencies, or registration non-compliance. Understanding scope and cause is the foundation of a successful petition — the specific import alert number and charge determine every subsequent step.
Laboratory Testing Guidance & Coordination
Many import alerts require laboratory testing as part of the removal evidence. LMG identifies the specific tests required — microbiological analysis, pesticide residue, heavy metals, identity, purity, potency, or other relevant analyses depending on the alert type — and provides guidance on selecting accredited laboratories. We ensure test reports are structured and formatted in a way that FDA will accept. Incorrectly formatted or incomplete results are among the most common reasons petitions are delayed or rejected.
ITACS System Upload
ITACS (Import Trade Auxiliary Communications System) is FDA's secure electronic portal for submitting import-related documentation — laboratory results and other supporting evidence — tied to specific detained entries. For most DWPE cases, evidence must be formally submitted through ITACS rather than by email or mail. LMG manages the upload on your behalf: preparing the required entry documentation, formatting findings to FDA standards, and uploading all files to the correct ITACS case linked to your entry.
Removal Petition Preparation & Submission
The final step is a formal written petition to FDA requesting removal of your firm or product from the import alert database. LMG prepares a complete, structured petition presenting the root cause analysis, the corrective actions taken, the supporting laboratory evidence, and a clear demonstration that the violation is resolved. The petition is submitted to the appropriate FDA office and followed up until FDA issues its removal decision.
Start Your Import Alert Removal
Contact LMG to discuss your situation. We will review the import alert, explain what is required, and provide a clear plan for the removal process.
Contact Us +1 (630) 270-2921LMG Compliance Monitor™
LMG US Agent clients receive 24-hour import alert surveillance at no additional cost. Know about any Red List change before your next shipment departs.
US Agent ServiceScope of LMG’s Assistance
LMG provides regulatory guidance and documentation services for the import alert removal process. Detained shipments at US ports are handled by the FDA district office at each specific port of entry, and on-site detention handling is the responsibility of the importer of record and their customs broker. Accordingly, LMG does not provide direct assistance with FDA detention officers at ports of entry. Our role is to prepare the regulatory evidence — root cause analysis, laboratory testing coordination, ITACS uploads, and formal petition — that supports your removal from the import alert database.
Frequently Asked Questions
What is DWPE and what does it mean for my shipments?
What exactly does LMG help with — and what is outside LMG's scope?
What is ITACS and how does it work?
What laboratory testing is typically required for import alert removal?
How long does import alert removal take?
Does LMG handle import alerts for all FDA-regulated product categories?
Start the Process
Is your firm on the FDA Red List?
Contact LMG to review your import alert situation. We will identify the exact charge, outline the required corrective steps, and guide you through the complete documentation and petition process.
Or call: +1 (630) 270-2921