IA #16-50, 5/4/01 - REVISION TO IMPORT ALERT #16-50, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF MOLLUSCAN SHELLFISH", ATTACHMENT - 9/15/08
This revision updates the text of the import alert and REMOVES a firm from the
Attachment and adds it to the attachment of Import Alert 16-81. Changes are
indicated by asterisks (***).
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION
(NOTE: This import alert represents the Agency's current
guidance to FDA field personnel regarding the
manufacturer(s) and/or product(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.)
PRODUCT: **Raw*** Molluscan shellfish
PRODUCT CODE: See Attachment
PROBLEM: Contains one or more of the following: Salmonella, Vibrio
cholera, other bacteria, viruses (e.g. Hepatitis A, Norwalk,
etc.), and/or the product is associated with a food-borne
illness outbreak based on epidemiological evidence. The
product may also be misbranded.
PAC: 03844 (for collection)
03844D (for analysis)
21844 (for misbranding)
PAF: MIC (microbiology)
LBL (labeling)
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER: See Attachment
CHARGE: For microbiological(including viruses)violations, charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain Salmonella,
Vibrio cholera, and/or other bacteria or viruses,
deleterious substances which may render it injurious to
health [Adulterated, Section 402(a)(1)]"
(OASIS Charge Code: BACTERIA)
For Epidemiological Evidence (Association with a Food-borne
Illness Outbreak), charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that it appears to have been
manufactured, processed, or packed under insanitary
conditions [Adulteration, Section 402(a)(4)]"
(OASIS Charge Code: MFR INSAN)
For labeling violations, charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the labeling of the product
appears to be false and misleading [Misbranded, Section
403(a)(1)]"(OASIS Charge code: FALSE)
RECOMMENDING
OFFICE: CFSAN/DIOP/SEA-DO
REASON FOR
ALERT: Examination of shipments of molluscan seafood from firms on
the attached list have been made. Salmonella, Vibrio
cholera, other bacteria and/or viruses (e.g. Hepatitis A,
Norwalk, etc.) were found, or epidemiological evidence
associated the product with a food-borne illness outbreak.
Additionally, some shipments were labeled as "cooked" when
in fact the product only received a minimal heat treatment
in order to "open" the shells.
GUIDANCE: Districts may detain, without physical examination, the
specified product from the manufacturers on the attached
list regardless of whether they are from a certified shipper
under the Interstate Certified Shellfish Program.
Removal of Firms from this Import Alert:
Firms (other than certified shellfish shippers) requesting
removal from this import alert will need to provide CFSAN,
office of Field Programs, HFS-606, with a detailed HACCP
plan for the foreign processor. This includes firms on the
alert due to labeling problems (cooked vs. raw); firms whose
products have been found with bacterial or viral
contamination; and firms whose products have been associated
with a food-borne illness outbreak. A copy of the petition
letter should be forwarded to DIOP, HFC-170.
Certified shellfish shippers can be removed from this Import
Alert when inspected and found in-compliance by the
country's competent authority with the National Shellfish
Sanitation Program (NSSP) as required by the MOU between the
United States and the signatory country. The competent
authority can then request that the certified shellfish
shipper be removed from this Import Alert by providing
evidence to CFSAN, Office of Field Programs, HFS-606. This
includes products that have been found with bacterial or
viral contamination and firms whose products have been
associated with a food-borne illness outbreak. A copy of the
petition letter should be forwarded to DIOP, HFC-170.
For questions or issues concerning science, science policy,
analysis, preparation, or analytical methodology, contact
the Division of Field Science at (301) 827-7605.
FOI: No purging required.
KEYWORD: ***Raw***, Molluscan, Seafood, Salmonella, Vibrio cholera,
Bacteria, Hepatitis A virus, Norwalk, Labeling, Food-Borne
Illness, Epidemiology
PREPARED BY: Linda Wisniowski, DIOP, 301-443-6553
Frank Sikorsky, CFSAN, HFS-606, 202-205-1922
DATE: LOADED
INTO FIARS: March 19, 2002
Attachment to Import Alert #16-50 9/15/08
FIRMS/PRODUCTS RECOMMENDED FOR DWPE
Firm Name and Address: Product/Code: Reason /Date of DWPE:
N. S. Super Enterprise Co., Ltd. Cockles Salmonella and
109 Pho Lane 16E[][]10 Vibrio cholera
Bangkok, Thailand 7/31/89
FEI# 13364
Shanghai International Trade Clams Hepatitis A
Development Corp. 16E[][]02 Virus
445 Jiang Ning Road, 11th Floor Raw product
Shanghai, China labeled as
FEI# 300260559 cooked
12/18/00
Hainan Fruit Vegetable Frozen Cooked Misbranded (raw
Food Allocation Co., Ltd. Green mussels on product labeled as
No. 21 Haiyu West Line the half shell frozen cooked)
Xiuying Area Hikou 16E[][]04 08/20/02
Hainan, China 4600/02007
FEI# 3002701920
Shipper:
Zhanjiang Guolian Aquatic
Products Co., Ltd.
Yongping South Road
Pingle Industry Region
Development Zhanjiang
Guangdong, China
FEI# 3003658988
Nam Hai Company Ltd. FROZEN RAW CLAM / 16E[][]02 Salmonella
279A Hung Vuong Street, 16X[][]30
An Lac Ward Binh Chanh Dist. 4/6/07
Ho Chi Minh City, Vietnam
FEI# 3004206311
Zhangzhou Gelin Seafoods Greenlip Mussels 16E[][]04 Misbranded
Geng Wei Town (raw product
Longhai City 4/14/03 labeled as
Fujian Province cooked)
China
FEI# 3003887017
Shipper:
Zhangzhou Foreign Trade Corp.
Foreign Trade Building
32 N Xinhua Road
Zhangzhou, Fujian Province
China
FEI# 1000368451
Pescanova C.C. Frozen Clams Salmonella 4/21/94
Calle Pegallo 16E[][]02 Coliforms
Galpon San Jose
Guiria, Sucre Frozen Oysters Salmonella 4/21/94
Venezuela 16E[][]03 Coliforms
FEI# 1000152168
Kien Giang Ltd. Frozen Cooked Salmonella
80/18a Ba Huyen Blood Clams in shell
Than Quan Dist. 3 16E[][]02
Ho Chi Minh City 3/30/04
Vietnam
FEI# 3003978428
Jose Arruda Limpets Salmonella
Hornal de Santa Luzia 16E[][]07
Ribeira Grande - Sao Miguel 3/29/06
Portugal
FEI # 3004807200
Vuon Loi Seafood Import Frozen Cooked Baby Clams Salmonella
And Export Corporation 16E[][]02
835/12 Tran Hung Dao St., 16J[][]99
HoChiMinh 4/17/06
Vietnam
FEI #3004262750
Frozen Cooked Whole Cockle Clams Salmonella,
16E[][]10 Misbranding
16E[][]02 (raw product
16J[][]99 labeled as
4/17/06 frozen cooked
Hua Heong Food Industries Vietnam Co Ltd. Whole Clam Misbranded
D3A-D3b Le Minh Xuan Industries Zone 16E[][]02 Raw sold as
Binh chanh Dist. 16X[][]30 cooked
Hochiminh City 2/14/08
Vietnam
FEI# 3003660754
FEI # 3004276822
Taishan Guanglong Foodstuff Dried Cooked Mussels Salmonella
Process Co., Ltd. 16E[][]04
No.1 Bld.3, Xincheng 16X[][]31
Development Zone 9/15/08
Guanghai, Taishan
China
FEI# 3005411740
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