Import Alert 99-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 99-01
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Surveillance of American Goods Returned"
Reason for Alert:
The term "American Goods Returned" applies to products manufactured in the United States, exported, then shipped back to the United States. The American consignee may or may not be the original manufacturer or distributor of the product.
The return of a U.S. manufactured or labeled product may signal possible problems with the product.
For example:
* products may be returned to the United States because the expiration date or shelf life has been exceeded;
* products may be returned having been rejected by a foreign consignee or refused entry by a foreign government due to adulteration or misbranding;
* products, which were legally exported for foreign distribution, but which are adulterated and/or misbranded because they do not meet the requirements of the Federal Food, Durg, and Cosmetic Act for domestic distribution, may be profitably resold to American consignees and shipped to them as "American Goods Returned" for sale in the United States; and
* foreign made counterfeit products may be invoice as genuine U.S. manufactured products previously exported, and entered as "American Goods Returned".
The return of a U.S. manufactured or labeled product may signal possible problems with the product.
For example:
* products may be returned to the United States because the expiration date or shelf life has been exceeded;
* products may be returned having been rejected by a foreign consignee or refused entry by a foreign government due to adulteration or misbranding;
* products, which were legally exported for foreign distribution, but which are adulterated and/or misbranded because they do not meet the requirements of the Federal Food, Durg, and Cosmetic Act for domestic distribution, may be profitably resold to American consignees and shipped to them as "American Goods Returned" for sale in the United States; and
* foreign made counterfeit products may be invoice as genuine U.S. manufactured products previously exported, and entered as "American Goods Returned".
Guidance:
American Goods Returned should be considered suspect. Districts should
seriously consider all entries of such products before release.
Determine the reason for the return of the goods. The goods should be wharf examined and sampled for laboratory examination if, in your judgment, there is reason to believe that an appearance of violation may exist. Consult with the appropriate Center for assistance, if needed.
Goods should be detained with the appropriate charge when they appear
violative, based on examination of samples or otherwise.
seriously consider all entries of such products before release.
Determine the reason for the return of the goods. The goods should be wharf examined and sampled for laboratory examination if, in your judgment, there is reason to believe that an appearance of violation may exist. Consult with the appropriate Center for assistance, if needed.
Goods should be detained with the appropriate charge when they appear
violative, based on examination of samples or otherwise.
Product Description:
Returned American Goods
Charge:
N/A
Countries
UNITED STATES
(00 - - - --) wildcard for customs
Desc:All products
Notes:Returned American goods
Notes:Returned American goods
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