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.