INTRODUCTION TO FDA'S IMPORT REFUSAL REPORT (IRR)
This report replaces the FDA import Detention Report(IDR). 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 IDR gave an incomplete picture in that it only reflected the initial action by the Agency and not the ultimate determination of the compliance status of the product. The IRR reports on those products for which the that determination was to refuse admission to the product. 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 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 importing community 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 Identifies the name of the foreign establishment responsible NAME for the product refused. MANUFACTURER Identifies the manufacturer's street address, city, province or state, and country. ADDRESS/CITY/ PROVINCE-STATE/COUNTRY PRODUCT CODE A unique identifier assigned to products regulated by FDA. IMPORTER'S The importer's description of the product offered for entry. PRODUCT DESCRIPTION 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/ A unique identifier for the product within an entry. An entry may SUFFIX have one or more of these number/letter identifiers. CARRIER The name of the carrier, the entity that transported the entry items. BILL OF LADING The bill of lading number. FDA SAMPLE ANALYSIS Yes or No flag indicating whether or not a FDA sample analysis was conducted. FDA RECORD OF PRIVATE Yes or No flag indicating whether or not FDA records show receipt of private laboratory LAB SAMPLE ANALYSIS 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.