Drug Import Alert
Removal Assistance
An FDA Import Alert places your drug product or facility on the Detention Without Physical Examination (DWPE) list — blocking shipments at the U.S. border and halting market access. FDA Registration Assistance guides foreign and domestic drug manufacturers through the full import alert removal process — from root cause analysis and corrective action planning to formal FDA petition submission and resolution.
What Is an FDA Import Alert & How Does Removal Work
An FDA Import Alert is an enforcement tool that places a drug product, manufacturer, or facility on the Detention Without Physical Examination (DWPE) list — authorizing U.S. Customs and Border Protection to detain shipments without individual inspection. Import alerts are issued for violations including adulteration, misbranding, lack of FDA registration, or manufacturing non-compliance. FDA Registration Assistance reviews your import alert status, identifies the root cause, prepares corrective action documentation, and files the formal petition required to restore U.S. market access.
FDA Registration Assistance reviews your drug product labels and ingredient declarations against current FDA labeling requirements — verifying format, content, claims, warnings, and active ingredients. Our review identifies compliance gaps before FDA review, reducing the risk of regulatory action or market delays for your drug products.
- Applies to foreign & domestic drug manufacturers
- Blocks all shipments to the U.S. without physical exam
- Removal requires corrective action & formal FDA petition
- Typically 5 consecutive compliant shipments required
- FDA Registration Assistance manages the full removal process
Our Drug Import Alert Removal Services
Everything drug manufacturers need to get removed from the FDA Import Alert DWPE list — from root cause analysis and corrective action planning to formal FDA petition preparation and post-removal compliance support, handled end-to-end by experienced FDA regulatory specialists.
Import Alert Case Review
FDA Registration Assistance reviews your FDA import alert status, identifies the specific violation(s) triggering the DWPE listing, and develops a targeted removal strategy tailored to your product and facility.
Corrective Action Planning
FDA Registration Assistance prepares a comprehensive corrective action plan addressing the root cause of the import alert — including manufacturing improvements, labeling corrections, and documentation updates required by the FDA.
FDA Petition Preparation & Filing
FDA Registration Assistance prepares and files the formal petition or request for removal from the DWPE list — including all required documentation, corrective action evidence, and compliance records submitted directly to the FDA.
Post-Removal Compliance Support
After removal from the DWPE list, FDA Registration Assistance provides ongoing compliance monitoring, registration maintenance, and guidance to prevent future import alerts and ensure continued U.S. market access.
Trusted FDA Import Alert Removal Specialists
Helping OTC and prescription drug companies ensure their labels and ingredients meet FDA requirements — before regulatory issues arise.
How Our Drug Import Alert Removal Service Works
A simple four-step process to review your drug product labels and ensure full FDA compliance before market.
Submit Your Import Alert Details
Provide your import alert number, affected product details, and facility information. FDA Registration Assistance reviews the DWPE listing and identifies the root cause.
Corrective Action Plan Developed
FDA Registration Assistance prepares a corrective action plan addressing all identified violations — including documentation, manufacturing corrections, and compliance evidence required for removal.
Petition Filed with FDA
FDA Registration Assistance submits the formal removal petition and all supporting documentation to the FDA — managing all communications and tracking the petition status through resolution.
Import Alert Removed & Compliant
Upon FDA approval, your product and facility are removed from the DWPE list. FDA Registration Assistance provides ongoing compliance support to maintain your U.S. market access and prevent future alerts.
Complete FDA Drug Registration Solutions
We offer a full range of FDA registration and compliance services to help your facility and shipments meet all U.S. regulatory requirements.
Drug Establishment Registration
Register your foreign or domestic drug manufacturing, repacking, or relabeling facility with the FDA — required for all drug products distributed in the U.S.
Labeler Code Registration
Obtain your FDA Labeler Code — required to identify your company on drug product labels and NDC numbers distributed in the United States.
NDC Code / Product Code
Register your National Drug Code (NDC) and product codes with the FDA — mandatory for all drug products commercially distributed in the U.S.
Drug Label & Ingredient Review
Ensure your drug product labels and ingredient declarations meet all FDA labeling requirements before entering the U.S. market.
DUNS Request Assistance
Obtain your DUNS Number required for FDA Drug Establishment Registration and federal compliance — filed accurately on your behalf.
Drug / OTC U.S. Agent Services
Designate a U.S. FDA Agent for your foreign drug establishment — legally required for all foreign drug facilities registered with the FDA.
FDA Drug Listing Certificate
Obtain your official FDA Drug Listing Certificate confirming your drug product is registered and listed with the U.S. Food and Drug Administration.
FDA Drug Master Files (DMF)
Submit an FDA Drug Master File (DMF) to protect confidential manufacturing information while supporting drug product applications and registrations.
Drug Import Alert Removal
Get expert help resolving FDA drug import alerts and detentions to restore your drug products' ability to enter the United States.
Frequently Asked Questions — FDA Drug Import Alert Removal
Find answers to the most common questions about FDA import alerts, DWPE removal requirements, and how FDA Registration Assistance guides drug manufacturers through the full import alert removal process.
What is an FDA Import Alert?
An FDA Import Alert is an enforcement tool that authorizes U.S. Customs and Border Protection to detain shipments of a specific product, manufacturer, or foreign facility without physical examination (DWPE). Import alerts are issued when the FDA identifies a pattern of violations including adulteration, misbranding, lack of registration, or GMP non-compliance.
What does DWPE mean?
DWPE stands for Detention Without Physical Examination. It means that U.S. Customs and Border Protection will automatically detain shipments of the listed product or from the listed facility at the U.S. border — without conducting an individual examination of each shipment. DWPE listings effectively block U.S. market access until the import alert is resolved.
Why would FDA issue an import alert against my product or facility?
FDA import alerts are typically issued for repeated GMP violations, adulteration, misbranding, lack of required FDA registration or drug listing, refusal of FDA inspection, fraudulent submissions, or failure to comply with FDA regulations. Foreign facilities are particularly susceptible if their products repeatedly fail testing or if the facility is found non-compliant during an FDA inspection.
How does FDA Registration Assistance help with import alert removal?
FDA Registration Assistance reviews your import alert status, identifies the specific violations triggering the DWPE listing, prepares a comprehensive corrective action plan, compiles all required documentation and compliance evidence, and submits the formal removal petition to the FDA. We manage all FDA communications throughout the process and provide post-removal compliance support.
What is typically required to be removed from an FDA Import Alert?
Removal from an FDA Import Alert DWPE listing typically requires submitting a formal petition demonstrating that the underlying violations have been corrected. This may include documentation of five consecutive compliant shipments (for some import alerts), a comprehensive corrective action plan, updated GMP compliance evidence, revised labeling, and corrected FDA registration records — depending on the specific reason for the alert.
How long does FDA import alert removal take?
The timeline for FDA import alert removal varies depending on the type of import alert, the nature of the violations, and the FDA's review workload. Some removals are resolved in a few months, while complex cases involving manufacturing non-compliance or GMP violations can take 12–24 months or longer. FDA Registration Assistance works to compile and submit a complete, well-documented petition to minimize delays.
Can a foreign manufacturer be placed on an FDA Import Alert?
Yes. Foreign manufacturers are frequently placed on FDA Import Alerts, particularly for GMP non-compliance, refusal of FDA inspection, lack of FDA establishment registration, adulterated products, or misbranded labeling. Foreign facilities without a U.S. Agent may also face import alert risk if FDA correspondence cannot be delivered. FDA Registration Assistance helps foreign manufacturers navigate the removal process from start to finish.
What types of FDA Import Alerts exist for drug products?
Common FDA Import Alerts for drug products include Import Alert 66-40 (drugs manufactured under conditions not in conformance with GMP), Import Alert 66-66 (unapproved new drugs), Import Alert 66-73 (misbranded drugs), and Import Alert 55-06 (adulterated dietary supplements). Each import alert has specific removal criteria that must be addressed in the formal petition.
Do I need a U.S. Agent to have an FDA Import Alert removed?
Foreign drug manufacturers are required to have a U.S. Agent registered with the FDA as part of their drug establishment registration under 21 CFR Part 207. Having an active U.S. Agent is essential during the import alert removal process — the FDA may send correspondence, inspection notices, and petition responses through your U.S. Agent. FDA Registration Assistance can serve as your U.S. Agent throughout the import alert removal and beyond.
What is the cost of FDA Import Alert removal assistance?
The cost of FDA Import Alert removal assistance varies based on the complexity of the case, the type of import alert, the number of products affected, and the volume of corrective action documentation required. FDA Registration Assistance provides a custom quote following an initial case review. Contact us to discuss your specific import alert situation and receive a tailored proposal.
Can FDA Registration Assistance remove my product from the DWPE list?
FDA Registration Assistance prepares and submits the formal removal petition and all supporting documentation on your behalf — managing all FDA communications throughout the process. While FDA Registration Assistance handles every aspect of the removal process, final removal decisions are made by the FDA. Our experience and thorough documentation help present the strongest possible case for removal from the DWPE list.
Will my shipments be detained while the removal petition is pending?
Yes. While the import alert removal petition is under FDA review, DWPE listings remain active and shipments of the affected product or from the affected facility may continue to be detained at the U.S. border. FDA Registration Assistance works to prepare a complete and well-documented petition to minimize the review period and restore U.S. market access as quickly as possible.
What is a corrective action plan for FDA import alert removal?
A corrective action plan (CAP) is a documented response to the FDA identifying the root cause of the violation that triggered the import alert, the specific corrective actions taken to address each violation, and the measures implemented to prevent recurrence. A well-prepared CAP is a critical component of the formal import alert removal petition and must be supported by objective evidence of compliance.
Can FDA Registration Assistance help with FDA inspection preparation?
Yes. For import alert cases involving GMP non-compliance or manufacturing violations, FDA inspection preparation is often an essential part of the removal strategy. FDA Registration Assistance helps drug manufacturers prepare for FDA inspections by reviewing SOPs, manufacturing records, quality systems, and facility documentation — ensuring you are fully prepared to demonstrate compliance to FDA investigators.
Is FDA import alert removal guaranteed?
No. FDA import alert removal cannot be guaranteed, as final removal decisions are made solely by the FDA based on their review of the submitted petition and supporting documentation. FDA Registration Assistance prepares thorough, well-documented removal petitions that present the strongest possible case — but outcomes depend on the FDA's assessment of the corrective actions and compliance evidence provided.
How do I get started with FDA Import Alert removal assistance?
Contact FDA Registration Assistance to begin your import alert removal case. Provide your FDA import alert number, affected product and facility details, and any existing corrective action documentation. FDA Registration Assistance will review your import alert status, identify the root cause, and develop a targeted removal strategy — providing a custom quote and timeline before any work begins.
Start Your FDA Import Alert Removal Today
Submit your import alert details and facility information and FDA Registration Assistance will review your DWPE listing, identify the root cause, and begin preparing your formal removal petition — working to restore your U.S. market access as quickly as possible.
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