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:


COUNTRY 	The country of origin of the FDA manufacturer. This may be different than the
		country of origin for U.S. Customs purposes. Note: This field is only provided 
		for the IDR sorted by product. 

MANUFACTURER 	Identifies the name and city of the foreign establishment responsible 
NAME/CITY 	for the product refused. 


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. 

PRODUCT CODE 	A unique identifier assigned to products regulated by FDA. 

PRODUCT 	Identifies or describes the product offered for entry. 
DESCRIPTION

DATE 		Identifies the date when the action was taken. 

REASON		Identifies the reason for the agency actions. The specific reason for the detention can be 
		accessed by double 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
		is a portion of the shipment being refused.