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: 05/28/2021
Type: DWPE with Surveillance

Import Alert Name:

"Detention Without Physical Examination of Coconut Due to the Presence of Microbiological Contamination"

Reason for Alert:

NOTE: The revision to this import alert dated 4/7/2020 updates the Reason for Alert, Guidance, and Charge sections. Changes are bracketed by asterisks (***).

On September 6, 1991, Baltimore District was informed by the Maryland Department of Health of an outbreak of cholera. Three individuals became ill and were found to be infected with toxigenic Vibrio cholerae 01, biotype El Tor, serotype Ogawa. 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 toxigenic V. Cholerae 01, serotype Ogawa, which was confirmed by CFSAN. The product was also found to contain Salmonella.

*** ***
In 2008, a sample of shredded coconut manufactured in India, was collected and analyzed and found to contain Listeria monocytogenes, Type 4.

Guidance:

Divisions may detain, without physical examination, all shipments of the specified coconut product(s) from the firms listed in the Red List below due to the presence of microbiological contamination, using the appropriate charges as noted.

*** Recommendations for additions to the Red List of this import alert, that are due to findings of Salmonella, should be forwarded directly to the Division of Import Operations (DIO).

Additions to the Red List of this import alert as a result of Listeria monocytogenes or Vibrio cholerae findings will require a review by both DIO and the Center. If other strains of Vibrio are encountered, these findings will be reviewed on a case-by-case basis by the Center.***

***Release of Articles Subject to Detention Without Physical Examination under This Import Alert:

To secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide the results of a private laboratory analysis of a representative sample(s) collected from the affected article as evidence that the product does not bear or contain the presence of microbiological contamination.***

***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this import alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov***

***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@FDA.HHS.GOV

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov***

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 monocytogenes, 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)


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


ANHUI WEIBO TRADITIONAL CHINESE MEDICINE CO.,LTD.
Date Published : 08/11/2020
South New District , Bozhou, CN-34 CHINA
21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 08/11/2020

Desc: Coconut
Problems: SALMONELLA;

21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 08/11/2020

Desc: Coconut
Problems: SALMONELLA;

23 B - - 05 Coconut, Shelled
Date Published: 08/11/2020

Desc: Coconut
Problems: SALMONELLA;

54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/11/2020

Desc: Coconut
Problems: SALMONELLA;

Kwok Fung International Development Ltd
Date Published : 09/16/2009
Western Centre 1005 40 , 50 Voeux Rd , West, Hong Kong CHINA
23 B - - 05 Coconut, Shelled
Date Published: 04/23/2021

Desc: Dessicated Coconut Coconut Milk
Notes: 7/23/1992; Problem; V.Cholerae
Problems: SALMONELLA;

23 C - - 05 Coconut, Butter
Date Published: 04/23/2021

Desc: Dessicated Coconut Coconut Milk
Notes: 7/23/1992; Problem; V.Cholerae
Problems: SALMONELLA;

23 D - - 05 Coconut, Paste
Date Published: 04/23/2021

Desc: Dessicated Coconut Coconut Milk
Notes: 7/23/1992; Problem; V.Cholerae
Problems: SALMONELLA;

23 E - - 05 Coconut, Spread
Date Published: 04/23/2021

Desc: Dessicated Coconut Coconut Milk
Notes: ;7/23/1992; Problem; V.Cholerae
Problems: SALMONELLA;

23 F - - 07 Peanut, Topping
Date Published: 04/23/2021

Desc: Dessicated Coconut Coconut Milk
Notes: 7/23/1992; Problem; V.Cholerae
Problems: SALMONELLA;

30 Y - - 02 Coconut Milk Beverage Base
Date Published: 04/23/2021

Desc: Dessicated Coconut Coconut Milk
Notes: 7/23/1992; Problem; V.Cholerae
Problems: SALMONELLA;


DOMINICAN REPUBLIC (THE)


Horizontes Mercantiles, C. Por A.
Date Published : 09/16/2009
Luis Felipe Vidal #118 , Azua Republica Dominicana, DOMINICAN REPUBLIC (THE)
23 F - - 05 Coconut, Topping
Date Published: 04/23/2021

Desc: Desiccated Coconut
Notes: 10/7/1997
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 (THE)
23 F - - 05 Coconut, Topping
Date Published: 04/23/2021

Desc: Desiccated Coconut
Notes: 10/7/1994
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
21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 05/28/2021

Desc: Coconut Shreds
Problems: SALMONELLA;

21 T - - 48 Coconut, Subtropical and Tropical Fruit, Dried or Paste
Date Published: 05/28/2021

Desc: Coconut Shreds
Problems: SALMONELLA;

23 A - - 05 Coconut, In Shell
Date Published: 05/28/2021

Desc: Coconut Shreds
Problems: SALMONELLA;

23 B - - 05 Coconut, Shelled
Date Published: 05/28/2021

Desc: Coconut Shreds
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
Anand Nadiad Road, 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: 05/28/2021

Desc: Shredded Coconut
Notes: 8/28/2007
Problems: LISTERIA : MONOCYTOGENES;


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

Desc: Grated Coconut
Problems: LISTERIA;

23 B - - 05 Coconut, Shelled
Date Published: 02/19/2016

Desc: Shredded Coconut
Notes: Problem: Vibrio Cholera

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

Desc: Grated 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
Problems: SALMONELLA;

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

Desc: Coconut
Problems: SALMONELLA;

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
Problems: SALMONELLA;

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

Desc: 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

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;