Import Refusal Advisory & Response Service
Comprehensive Support for Resolving FDA Import Refusals
An FDA Import Refusal can disrupt your supply chain and delay market entry. At U.S. Agents, we provide specialized advisory and coordination services to help importers effectively respond to FDA refusals and detentions. Our experienced team works alongside accredited labs, sampling professionals, and regulatory experts to guide you through each step of the resolution process.
We simplify the complex so you can stay focused on your business.
Import Entry Review & Compliance
Product classification (HTS/FD flags)
Electronic submission of entry data (ACE/ITDS)
Affirmation of compliance codes (AofC)
Real-time entry status via ITACS
Detention, Refusal & Hearing Support
Respond to FDA Notices of Action
Prepare supporting testimony and documentation
Assist with FDA hearings to contest potential destruction
Coordinate with compliance officers and CBP
Import Alerts & DWPE Resolution
Determine if your product is subject to Import Alerts
Secure documentation to demonstrate compliance
Assist with removal from DWPE list
Reconditioning plan development & submission
Products We Help With
Human & animal food, dietary supplements
Drugs (Rx & OTC), biologics
Cosmetics & personal care products
Medical devices & diagnostic tools
Radiation-emitting products
Tobacco & nicotine delivery systems
Administrative Destruction Prevention
Identify risk factors for international mail destruction (value < $2,500)
Prepare rebuttals against misbranding or adulteration claims
Avoid common triggers for refusal and mail seizure
ITACS Support & Management
ITACS entry setup and training
Uploading documentation, tracking status, and retrieving FDA decisions
Establishment of corporate-level ITACS accounts
OUR STEP-BY-STEP SUPPORT PROCESS
Case Intake & Initial Assessment
Submit your FDA Notice of Action to our Import Refusal Response Team. We’ll review the notice and determine the necessary next steps.
Document Evaluation & Compliance Guidance
We analyze your paperwork, identify any gaps, and advise on additional documentation needed for a compliant response.
Service Quote & Timeline Proposal
Receive a clear quote for services along with an estimated turnaround time tailored to your product category and refusal reason.
Sampling Coordination & Verification
We arrange professional sampling through FDA-compliant samplers, ensuring all procedural and documentation requirements are satisfied.
Laboratory Testing Facilitation
We coordinate testing with FDA-accredited labs to produce the necessary compliance data aligned with regulatory standards.
Response Submission & FDA Communication
We compile the final response package and submit it through ITACS, while assisting in any necessary communications with the FDA regarding the status of your import refusal case.
Work With U.S. Agents
Let us help you navigate your import refusal response with confidence and clarity.
Contact U.S. Agents today to learn how we can assist with your FDA import refusal case.
DISCLAIMER
U.S. Agents provides advisory, coordination, and administrative services to assist clients in addressing FDA import refusals and related regulatory challenges. We do not guarantee, warrant, or represent that any product will be released, approved, or cleared by the FDA. All final decisions regarding product compliance and admissibility are solely determined by the FDA. Clients remain responsible for ensuring their products comply with all applicable regulations.
Trusted Expertise in FDA Import Refusals
We’ve supported numerous clients in responding to FDA import refusals, facilitating timely and effective resolution pathways aligned with regulatory expectations.
Seamless Coordination Across Stakeholders
U.S. Agents simplifies the process by acting as your central coordination point for sampling, testing, documentation, and FDA submission—reducing the need to manage multiple service providers.
Nationwide Access to FDA-Compliant Resources
We leverage a broad network of FDA-compliant labs and professional samplers to ensure your case receives accurate, timely data support wherever your goods are detained.
FDA Import Refusals
U.S. Food and Drug Administration Import Refusal Reports for OASIS
INTRODUCTION TO FDA'S IMPORT REFUSAL REPORT (IRR)
The Food, Drug, and Cosmetic Act (the Act) authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. The FDA district office will then issue a "Notice of FDA Action" specifying the nature of the violation to the owner or consignee. The owner or consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another "Notice of FDA Action" refusing admission to the product. The product then has to be exported or destroyed within 90 days.
The IRR reports on those products for which a determination was to refuse admission to part or all of the product offered for importation.
The IRR is generated from data collected by FDA's Operational and Administrative System for Import Support (OASIS) and is updated monthly. Each month, the IRR is available sorted by country/area and by product based on the industry code which is the first two characters of FDA's product code (e.g., all fishery/seafood products will be coded 16...).
FDA has prepared this information in an effort to provide the public with information on products that have been found to appear in violation of the Act.
THE IRR PROVIDES THE FOLLOWING INFORMATION:
MANUFACTURER FEI - An identifier assigned internally by FDA for each firm/location.
MANUFACTURER NAME - Identifies the name of the establishment declared as being responsible for the product refused.
MANUFACTURER/ADDRESS/CITY/PROVINCE-STATE/COUNTRY - Identifies the manufacturer's street address, city, province or state, and country/area.
PRODUCT CODE - A unique identifier assigned to products regulated by FDA.
FDA PRODUCT DESCRIPTION - The FDA's description of the product offered for entry.
REFUSAL DATE - Identifies the date when the action was taken.
FDA DISTRICT - Identifies FDA District Offices that have jurisdiction over the refused product.
ENTRY NO. - A unique identifier assigned to each entry.
DOCUMENT/LINE/SUFFIX - A unique identifier for the product within an entry. An entry may have one or more of these number/letter identifiers.
FDA SAMPLE ANALYSIS - Yes or No flag indicating whether or not a FDA sample analysis was conducted.
FDA RECORD OF PRIVATE LAB SAMPLE ANALYSIS - Yes or No flag indicating whether or not FDA records show receipt of private laboratory analysis results package.
CHARGES - Identifies the reason for the agency actions. The specific reason for the refusal can be accessed by clicking the reason given in the IRR or by searching under the file titled "Violation Code Translations".
Partial Refusal - If this is present on a listing, it means that there was a reconditioning action which resulted in a portion of the shipment being refused.