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U.S. Department of Health and Human Services

Import Refusal Report

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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.

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