Import Alert 23-12

(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: 10/03/2019
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 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.

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)


BOLIVIA


Import & Export Santa Catalina INC.
Date Published : 06/26/2018
Av. Petrolera Km. 4 1/2 # 1358 , Av. Ayacucho # 127 , Cochabamba, BO-C BOLIVIA
23 B - - 05 Coconut, Shelled
Date Published: 06/26/2018

Desc: Coconut
Notes: 3/13/06
Problems: SALMONELLA;


CHINA


Kwok Fung International Development Ltd
Date Published : 09/16/2009
1005 Western Centre, 40-50 Voeux Rd , West Hong Kong, CHINA
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;


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


Kenel Normil
Date Published : 06/20/2018
Route Nationale # 1 Bon Repos , Port Au Prince, HAITI
23 F - - 05 Coconut, Topping
Date Published: 06/20/2018

Desc: Dried Coconut
Problems: SALMONELLA;

Tropic S.A. I
Date Published : 09/16/2009
Carrefour Shada , Route Nationale No 1 , Port Au Prince, None of the above HAITI
23 B - - 05 Coconut, Shelled
Date Published: 09/16/2009


INDIA


ADF Foods Limited
Date Published : 10/14/2011
77, 83/86 Gidc Industrial Estate , Nadiad, Gujarat INDIA
23 B - - 05 Coconut, Shelled
Date Published: 10/14/2011

Desc: Coconut
Problems: SALMONELLA;

FAVOUR-ITA INTERNATIONAL
Date Published : 06/26/2018
39 3519 Cochin , Ernakulam, Kerala INDIA
23 B - - 05 Coconut, Shelled
Date Published: 06/26/2018

Desc: Coconut
Notes: 5/13/03
Problems: SALMONELLA;

KAIRALI IMPORTS AND EXPORTS
Date Published : 09/01/2016
KUDUMULAYIL , RAILWAY STATION ROAD , HARIPAD, ALLEPPEY DIST, Kerala INDIA
21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 09/01/2016

Desc: Coconut Cuts
Problems: SALMONELLA;

KOCHI KITCHEN EXPORTS
Date Published : 02/08/2018
23/1777 Binny Road , Kochi, Kerala INDIA
21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 02/08/2018

Desc: Grated Coconut (Fresh and Frozen)
Problems: LISTERIA : MONOCYTOGENES;

21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 02/08/2018

Desc: Grated Coconut (Fresh and Frozen)
Problems: LISTERIA : MONOCYTOGENES;

23 B - - 05 Coconut, Shelled
Date Published: 02/08/2018

Desc: Grated Coconut (Fresh and Frozen)
Problems: LISTERIA : MONOCYTOGENES;

MATHA FOODS EXPORTS & MANUFACTURES OF FROZEN FOODS
Date Published : 09/01/2016
KP 4/684. Monthachal Road , Chamanad, Kothiyathodu P.O. , Aleppey, Kerala INDIA
21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 09/01/2016

Desc: Coconut Cuts
Problems: SALMONELLA;

MZ Food Products Private Limited
Date Published : 10/02/2018
Opp Kanjari Bus - Stop , Kanjari, Gujarat INDIA
23 B - - 05 Coconut, Shelled
Date Published: 10/02/2018

Desc: Shredded Coconut
Problems: SALMONELLA;

Oasis Exporters
Date Published : 06/26/2018
35/1698 Vallakkadavu Trivandrum , Kerala, INDIA
23 B - - 05 Coconut, Shelled
Date Published: 06/26/2018

Desc: Coconut
Notes: 5/19/03
Problems: SALMONELLA;

Temptation Foods Ltd
Date Published : 09/16/2009
Plot No -C2, MIDC, Jejuri , Tal : Purandhar , Pune, Maharashtra INDIA
23 A - - 05 Coconut, In Shell
Date Published: 09/16/2009

Problems: LISTERIA;


LEBANON


Alhwasly Bross
Date Published : 06/26/2018
Baabada Elkhandaa St Yaghi Bldg , Beirut, LEBANON
23 B - - 05 Coconut, Shelled
Date Published: 06/26/2018

Desc: Mashrouha Marzipan
Problems: SALMONELLA;

33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 06/26/2018

Desc: Mashrouha Marzipan
Problems: SALMONELLA;


MEXICO


El Azteca Dulces y Golosinas de Mexico S.A. de C.V.
Date Published : 06/26/2018
Calzada Independencia Norte 445 , barrio El Retiro , Guadalajara, Jalisco MEXICO
23 D - - 05 Coconut, Paste
Date Published: 06/26/2018

Desc: Yellow Coconut Candy
Problems: SALMONELLA;

33 H - - 03 Fondant Candy Bar, Soft, with Coconut (without Chocolate)
Date Published: 06/26/2018

Desc: Yellow Coconut Candy
Problems: SALMONELLA;

33 H - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Coconut (without Chocolate)
Date Published: 06/26/2018

Desc: Yellow Coconut Candy
Problems: SALMONELLA;

33 S - - 05 Marzipan, Coconut Roll (without Chocolate)
Date Published: 06/26/2018

Desc: Yellow Coconut Candy
Problems: SALMONELLA;


PHILIPPINES


Jo-Na's International Philippines Inc
Date Published : 09/16/2009
17 Clemente Street Bgy San Augustin , Novaliches, Quezon City PHILIPPINES
30 Y - - 02 Coconut Milk Beverage Base
Date Published: 10/01/2009

Problems: SALMONELLA;

Mofels Food International Corporation
Date Published : 02/18/2015
Governor's Drive , Brgy. Langkaan 1 , Cavite, Calabarzon PHILIPPINES
23 B - - 05 Coconut, Shelled
Date Published: 02/19/2016

Desc: Shredded Coconut
Notes: Problem(s): Vibrio cholera

23 B - - 05 Coconut, Shelled
Date Published: 02/18/2015

Desc: Grated Coconut

Sea-Land Harvest, Inc.
Date Published : 10/27/2016
Lot E, Navotas Fish Port Complex , North Bay Boulevard; -North; City , Navotas, National Capital Region PHILIPPINES
23 B - - 05 Coconut, Shelled
Date Published: 10/27/2016

Desc: Frozen Grated Coconut
Problems: SALMONELLA;

TBN FOOD PRODUCTS
Date Published : 07/17/2018
9126 Sampalukan Street , San Roque , Sto Tomas, Batangas PHILIPPINES
23 B - - 05 Coconut, Shelled
Date Published: 07/17/2018

Desc: Frozen Shredded Young Coconut
Problems: SALMONELLA;

Y.E.S. Export & Import Corporation
Date Published : 11/08/2018
Km.47 Rfm Road , Barangay Pulo , Cabuyao City, Laguna PHILIPPINES
23 B - - 05 Coconut, Shelled
Date Published: 11/08/2018

Desc: Shredded Coconut
Problems: VIBRIO : FLUVIALIS;

Y.E.S. Export & Import Corporation
Date Published : 11/08/2018
71 Santander Compound, Santander Lane , Quezon City, PHILIPPINES
23 B - - 05 Coconut, Shelled
Date Published: 11/08/2018

Desc: Shredded Coconut
Problems: VIBRIO : FLUVIALIS;


PORTUGAL


Condi Alimentar SA
Date Published : 02/23/2012
Rua dos Palmares , Camarate, Lisboa PORTUGAL
23 B - - 05 Coconut, Shelled
Date Published: 02/23/2012

Desc: Dried Shredded Coconut
Problems: SALMONELLA;


SRI LANKA


SRS FRUIT N SPICES (PVT) LTD
Date Published : 04/20/2018
Demanhandiya , 145, Divulapitiya Road , Negambo, Gampaha SRI LANKA
21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 04/20/2018

Desc: Coconut

23 B - - 05 Coconut, Shelled
Date Published: 04/20/2018

Desc: Coconut

SRS FRUIT N SPICES (PVT) LTD
Date Published : 04/20/2018
Baseline Avenue , 14/9 Marttrerace , Colombo, Colombo SRI LANKA
21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 04/20/2018

Desc: Coconut

23 B - - 05 Coconut, Shelled
Date Published: 04/20/2018

Desc: Coconut


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

NATURAL MUNCH CO., LTD
Date Published : 10/03/2019
Prime Estate 102/16 Moo2, Theparak Rd , Bang Sao Thong, Samutprakarn, THAILAND
07 G - - 08 Tropical/Subtropical Fruit Snacks, Fruit Snack Foods, Baked
Date Published: 10/03/2019

Desc: COCONUT CHIPS
Problems: SALMONELLA;


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


Agrimexco
Date Published : 06/27/2018
176 Hai Ba Trung St , District 1 , Ho Chi Minh City, VIETNAM
23 B - - 05 Coconut, Shelled
Date Published: 06/27/2018

Desc: Coconut
Problems: SALMONELLA;

Hai Minh
Date Published : 06/26/2018
43 Tran Van Cham St , Tan Thong Hoi Ward , Cu Chi District, VN-65 VIETNAM
23 B - - 05 Coconut, Shelled
Date Published: 06/26/2018

Desc: Frozen Coconut; Sliced
Problems: SALMONELLA;

Hua Heong Food Industries (Vietnam) CO., Ltd
Date Published : 06/26/2018
D3a-D3b Le Minh Xuan, Industrial Zone , Binh Chanh District , Ho Chi Minh, Vn-65 VIETNAM
23 B - - 05 Coconut, Shelled
Date Published: 06/26/2018

Desc: Coconut
Problems: SALMONELLA;

Lucky Shing Co., Ltd.
Date Published : 01/24/2018
An Thanh Village, Ben Luc District , No. 3, 108/1, Road No. 830, Hamlet , Long An Province, VIETNAM
03 R - - 01 Cake Without Custard or Cream Filling
Date Published: 03/15/2018

Desc: Frozen/Refrigerated Coconut Cake
Notes:                                                                                                         
Problems: SALMONELLA;

03 Y - - 99 Other Bakery Products, N.E.C.
Date Published: 03/15/2018

Desc: Frozen/Refrigerated Coconut Cake
Notes:                                                                                                         
Problems: SALMONELLA;

21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 03/15/2018

Desc: Frozen/Refrigerated Coconut
Notes:                                                                                                         
Problems: SALMONELLA;

21 U - - 48 Coconut, Subtropical and Tropical Fruit, Jams, Jellies, Preserves, Marmalades, Candied, Butters, Spr
Date Published: 03/15/2018

Desc: Frozen/Refrigerated Young Coconut
Notes:                                                                                                         
Problems: SALMONELLA;

21 X - - 48 Coconut, Subtropical and Tropical Fruit Pulp
Date Published: 03/15/2018

Desc: Frozen/Refrigerated Coconut
Notes:                                                                                                         
Problems: SALMONELLA;

23 B - - 05 Coconut, Shelled
Date Published: 03/15/2018

Desc: Frozen/Refrigerated Coconut
Notes:                                                                                                         
Problems: SALMONELLA;

23 B - - 05 Coconut, Shelled
Date Published: 01/24/2018

Desc: Frozen Shredded Coconut
Problems: SALMONELLA;

PHU THUAN CORPORATION
Date Published : 09/16/2009
Binh Thanh District , 146, No Trang Long Str , Hochiminh, Vn-65 VIETNAM
23 F - - 05 Coconut, Topping
Date Published: 10/01/2009

Problems: SALMONELLA;