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Import Alert 23-12

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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 # 23-12
Published Date: 03/30/2013
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination of Coconut Due to the Presence of Microbiological Contamination"

Reason for Alert:
On September 6, 1991, Baltimore District was informed by the Maryland State Department of Health of an outbreak of Cholera. Three individuals became ill and were found to be infected with Cholera. The strain was confirmed by CDC as Vibrio Cholerae, 01, Ogawa, El Tor, Toxigenic N. The product implicated in this outbreak was a dessert made with coconut milk.

A number of different products were collected by Baltimore district as a result of a follow-up investigation; laboratory analysis of a sample of fresh frozen coconut milk identified the presence of V. Cholerae, 01, Ogawa, Toxigenic, which was confirmed by CFSAN. The product was also found to contain Salmonella.

The product contaminated with V. Cholerae is Asian Best Brand of frozen fresh coconut milk packed in 8 oz. plastic bags. The manufacturer is identified as CHAMP GROUP ENTERPRISE CO., LTD., Bangkok, Thailand. The product was distributed in Asian specialty markets along the east coast and in the midwest by b(4)                                       . Other shippers and/or distributors have not been identified.

A separate sample of a different product, from the same manufacturer, coconut candy was found to contain Salmonella.

In 2008, A sample of shredded coconut from an Indian firm was collected and analyzed and found to contain Listeria monocytogenes Type 4.

Guidance:
Districts may detain, without physical sampling and analysis, all shipments of the specified coconut product(s) from the manufacturers/shippers listed in the Red List below due to the presence of microbiological contamination, using the appropriate charges as noted.

Product Description:
All fresh, frozen and dried products containing coconut milk or coconut meat. NOTE: This does not include thermally processed canned products.

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Vibrio Cholerae, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]."

OASIS charge code: VIBRIO

and/or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]."

OASIS charge code: SALMONELLA

and/or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Listeria, a poisonous and deleterious substance which may render it injurious to health.[Adulteration, Section 402(a)(1)]."

OASIS charge code: LISTERIA


List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)



DOMINICAN REPUBLIC

Horizontes Mercantiles, C. Por A.
Date Published : 09/16/2009

Luis Felipe Vidal #118 , Azua Republica Dominicana, DOMINICAN REPUBLIC
23 D - - 05 Coconut, Paste
Date Published: 09/16/2009

Problems: SALMONELLA;

Selecta Agroindustrial S A - Calle "D" Esquina "G"
Date Published : 09/16/2009

Calle D & Esquina G, (Corner D & G Sts) , Box 20211, Zona Industrial De Haina , Santo Domingo, San Cristobal DOMINICAN REPUBLIC
23 D - - 05 Coconut, Paste
Date Published: 09/16/2009

Problems: SALMONELLA;


HAITI

Tropic S.A. I
Date Published : 09/16/2009

Route Nationale No 1 , Carrefour Shada , Port Au Prince, HT-NOTA HAITI
23 B - - 05 Coconut, Shelled
Date Published: 09/16/2009



HONG KONG

Kwok Fung International Development Ltd
Date Published : 09/16/2009

1005 Western Centre, 40-50 Voeux Rd , GPO Box 754 , West Hong Kong, HONG KONG
23 - - - -- Nuts/Edible Seed
Date Published: 09/16/2009

Notes:Dessicated Coconut; Coconut milk
Problems: SALMONELLA;
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 09/16/2009

Problems: SALMONELLA;


INDIA

ADF Foods Limited
Date Published : 10/14/2011

83 & 86 GIDC Industrial Estate , Nadiad, Gujarat INDIA
23 B - - 05 Coconut, Shelled
Date Published: 10/14/2011

Desc:Coconut

INNOVATIVE FOODS LTD
Date Published : 05/18/2012

EZHUPUNNA.P.O, ALAPPUZHA DIST , KERALA, INDIA , EZHUPUNNA, IN-KL INDIA
23 B - - 05 Coconut, Shelled
Date Published: 05/18/2012

Desc:Coconut
Notes:V. Cholera; V. Fluvial

Temptation Foods Ltd.
Date Published : 09/16/2009

C-2, MIDC, Taluka Purandar , Pune District , Jejuri, Maharashtra INDIA
23 A - - 05 Coconut, In Shell
Date Published: 09/16/2009

Problems: LISTERIA;


PHILIPPINES

Jo-Na's International Philippines Inc
Date Published : 09/16/2009

17 Clemente Street Bgy San Augustin , P O BOX 1560 (Metro Manila) , Novaliches, Quezon City PHILIPPINES
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 10/01/2009

Problems: SALMONELLA;


PORTUGAL

Condi-Alimentar,SA
Date Published : 02/23/2012

Quinta Dos Palmares , Fetais 2685 , Camarate, PT-NOTA PORTUGAL
23 B - - 05 Coconut, Shelled
Date Published: 02/23/2012

Desc:Dried Shredded Coconut
Problems: SALMONELLA;


THAILAND

Champ Group Enterprise Co Ltd
Date Published : 09/16/2009

766/48-53 Soi Pradu 1 Charoen Krung Rd , Yanawa BKK , Bangkok, THAILAND
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 10/01/2009

Problems: SALMONELLA;

Jack Hong Company Ltd.
Date Published : 09/16/2009

452-454 Biphya Road , Bangkok, THAILAND
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 10/01/2009



UNITED KINGDOM

LUBNA FOODS LTD
Date Published : 03/30/2013

164 GARNETT STREET , Bradford, West Yorkshire UNITED KINGDOM
21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 03/30/2013

Desc:Coconut
Problems: SALMONELLA;


VIETNAM

Phu Thuan Company
Date Published : 09/16/2009

Trang Long St. , Binh Thanh District , Hochiminh City, Vn-65 VIETNAM
23 F - - 05 Coconut, Topping
Date Published: 10/01/2009

Problems: SALMONELLA;

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