IA #23-12, REVISED 3/20/09, IMPORT ALERT 23-12 "DETENTION WITHOUT PHYSICAL
EXAMINATION OF COCONUT DUE TO THE PRESENCE OF MICROBIOLOGICAL CONTAMINATION"
ATTACHMENT REVISED 3/20/09
NOTE: The revision to this import alert dated 3/20/2009 updates the title,
updates applicable charges, and updates the guidance to the field. Changes are
bracketed by asterisks (***).
*** (Note: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer (s) and/or products 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).****
TYPE OF ALERT: ***Detention Without Physical Examination***
PRODUCT: All fresh, frozen and dried products containing coconut milk or
coconut meat.
(Note: This does not include thermally processed canned products.)
PRODUCT CODE: 33A [] [] 06 Coconut Candy
33B [] [] [] Hard Candy with Coconut
33H [] [] [] Soft Candy with Coconut
33S [] [] 05 Candy Specialties- Marzipan,
Coconut rolls
34D [] [] [] Chocolate...Candy with Coconut
30Y [] [] 02 Coconut Milk
23[][] [] 05 Coconut products including
Coconut milk
23B [] [] 05 Shelled Nuts, Coconuts
23B [] [] 17 Shelled Nuts, Coconut Sport
23C [] [] 05 Nuts Butters, Coconuts
23C [] [] 17 Nut Butters, Coconut Sport
23D [] [] 05 Nut Pastes, Coconuts
23D [] [] 17 Nut Pastes, Coconut Sport
23E [] [] 05 Nut Spreads, Coconuts
23E [] [] 17 Nut Spreads, Coconut Sport
23F [] [] 05 Nut Toppings, Coconuts
23F [] [] 17 Nut Toppings, Coconut Sport
35D [] [] 06 Pudding Mixes..., Coconut
PROBLEM: ***Microbiological Contamination***
PAC FOR
COLLECTION: ***03819C -- Microbiological ***
COUNTRY See Attachment
MANUFACTURER/
SHIPPER: See Attachment
CHARGES: *** "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 ***
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 ^
^. 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 Attachment to this alert due to
the presence of microbiological contamination, using the appropriate
charges as noted.***
RECOMMENDING
OFFICE: Baltimore District (HFR-MA200)
DIOP (HFC-170)
FOI: Purging of information between ^ ^ is required.
KEYWORDS: Cholerae, Salmonella, coconut milk, coconut meat, ***Listeria,
Vibrio, V.Cholerae***.
***ORGINAL ISSUE
DATE***: April 14, 1994
***ORIGINAL
PREPARED
BY***: Marvin A. Blumberg, DIOP
*** REVISED BY: William Keck, DIOP, 301-594-3855, 3/20/2009***
DATE LOADED
INTO FIARS: March 20, 2009
Attachment - Import Alert #23-12 Revised 3/20/09
FIRM NAME AND ADDRESS PRODUCT/ PROBLEM
PRODUCT CODE
DOMINICAN REPUBLIC
Selecta Agroindustrial, S.A. Desiccated Coconut Salmonella
Calle "D" Esquina "G" 23[][][]05
Zona Industrial De Haina 10/7/94
Box 20211, San Cristobal
Santo Domingo, Dominican Rep.
FEI: 1000211384
(Shipper)
Horizontes Mercantiles, Desiccated Coconut Salmonella
C. Por A. Luis Felipe Vidal #118 23[][][]05
Azua, Dominican Rep. 10/7/94
FEI: 1000186577
HAITI
Tropical Valley Foods S.A. Dried Coconut
Salmonella
Route Nationale #1 Bon-Repos 23B[][]05
Port-au-Prince, Haiti 2/27/05
FEI# 3004687095
HONG KONG
(Shipper)
Kwok Fung Trading Co. Dessicated Coconut V. cholerae
G.P.O. Box 754 Cocounut Milk5 Salmonella
1005 Western Centre 23[][][]05
40-50 Voeux Rd 30Y[][]02
Hong Kong 7/23/92
FEI: 3002400681
INDIA (IN)
Temptation Foods Ltd. Shredded Coconut L.monocytogenes
C-2, MIDC, Taluka Purandar 23A[][]05
Pune District, Jejuri 3/20/09
Maharashtra, India
FEI: 3006192697
PHILIPPINES
Jo-Na's International Philippines Coconut Milk Salmonella
17 Clemente Street 30Y[][]02
Bgy San Augustin 7/23/92
P.O. Box 1560
Novaliches, Quezon City (Metro Manila)
Philippines
FEI: 9112
THAILAND
Champ Group Enterprise Co. Ltd. Coconut Milk V. cholerae
766/48-53 Soi Pradu 1 30Y[][]02 Salmonella
Charoen Krung Rd. 7/23/92
Yanawa, BKK (Bangkok)
Thailand
FEI:12884
(Shipper)
Jack Hong Company Ltd. Coconut Milk Salmonella
452-454 Biphya Road 30Y[][]02 V.cholerae
Bangkok, Thailand 7/23/92
FEI: 13595
VIETNAM
Phu Thuan Company Shredded Coconut Salmonella
Trang Long St. (Dua Bao(Nhuyen))
Binh Thanh District 23F[][]05
Hochiminh City, Vietnam 4/4/06
FEI# 3005191200
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