IA# 12-10, 6/17/03, IMPORT ALERT #12-10, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF CHEESE DUE TO SALMONELLA, E. COLI, AND S. AUREUS" Attachment
revised 11/16/04
This revision to the attachment of this import alert deletes reference to
alkaline phosphatase. The text of the import alert remains the same.
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: ALL Cheese and cheese product(s)
PRODUCT CODE: 12[][][][][] (All cheese and cheese product(s))
HARMONIZED
CODE: N/A
PROBLEM: Escherichia coli (E. coli)(FLEC)
Salmonella (FLEC)
Staphylococcus aureus (S. aureus)(FLST)
Escherichia coli (E. coli) (ETEC)
PAC FOR
COLLECTION: 03037
PAF FOR
COLLECTION: MIC (Microbiological contamination)
COUNTRY: See attachment
NOTE: See IA #12-11 for guidance on cheese from El Salvador
MANUFACTURER/
SHIPPER: See attachment
MANUFACTURER/
SHIPPER I.D.#: See attachment
IMPORTER'S
I.D. #: N/A
CHARGE: For Salmonella, enterotoxigenic E. coli and Staphylococcal
enterotoxin charge:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to bear or contain
Salmonella, or entetrotoxigenic E. coli, or Staphylococcal
enterotoxin a poisonous or deleterious substance, which may
render it injurious to health [Adulteration, Section
402(a)(1)."
and/or
For S. aureus or E. coli charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears that it has been
prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health
[Adulteration, Section 402(a)(4)]."
RECOMMENDING
OFFICE: HFR-NE152 New York Import Operations Branch
HFR-PA2525 LOS-DO Import Branch
HFR-MA270 BLT-DO Import Operation Group
REASON FOR
ALERT: New York import branch collected samples of gorgonzola and
butter kase cheese for microbiological examination.
Analysis by the Northeast Regional Laboratory found the
shipments to contain E. coli at excessive levels.
Also, Los Angeles import branch collected a sample of
Mexican soft ranch cheese and analysis found the product to
contain Enterotoxigenic E. coli and excessive levels of E.
coli.
BLT-DO analysis of a sample of cheese from Honduras entered
through Dulles Airport revealed the presence of Salmonella,
S. aureus and E. coli.
The cheese was sampled due to positive findings of
Salmonella, S. aureus and E. coli in similar cheese from El
Salvador, which is the subject of Import Alert #12-11.
An attachment to this alert is being established to include
manufacturers and products which are found to contain
excessive levels of E. coli, S. aureus, or which contain
Salmonella or enterotoxigenic E. coli, or Staphylococcal
enterotoxin.
(NOTE: Due to the age of the samples submitted to the Center
for Food Safety and Applied Nutrition for review (January,
1996 detention), DIOP is not including the firms and
products identified by the New York import branch and Los
Angeles import branch at this time. However, we are issuing
this alert to provide guidance to field offices to indicate
support by the Center for Food Safety and Applied Nutrition
for such actions.)
GUIDANCE: Districts may detain without physical examination all cheese
and cheese product(s) from the identified manufacturers on
the attachment to this import alert. The violative
microbiological findings of concern are referenced on the
attachment to this alert.
The Division of Import Operations and Policy will coordinate
concurrence with CFSAN on E. coli, S. aureus, and
Salmonella. For questions or issues concerning science,
science policy, or analytical methodology, contact the
Division of Field Science at (301) 827-7605.
Refer to the Domestic and Import Cheese and Cheese Product
Compliance Program (7303.037) for guidance on product
coverage, sample collection, sample preparation, and sample
analysis.
Refer to Import Alert #12-11 for guidance on cheese from El
Salvador.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required.
KEYWORDS: Cheese, E. coli , Coliform, Salmonella, Staph, S. aureus
PREPARED BY: Linda Wisniowski, DIOP, 301-443-6553
DATE LOADED
INTO FIARS: JUNE 17, 2003
ATTACHMENT TO IMPORT ALERT 12-10 11/16/04
MANUFACTURERS RECOMMENDED FOR DETENTION WITHOUT PHYSICAL EXAMINATION.
APPLIES TO ALL CHEESE AND CHEESE PRODUCT(S) FROM THE REFERENCED MANUFACTURERS
FOR THE SPECIFIED PROBLEM(S)
BOLIVIA (BO)
FIRM PRODUCT PROBLEM
Corporacion Industrial Soft ripened cheese E. coli
Dillmann Cordill S.A. "Queso Criollisimo***
Av Blanco Galindo PEQ SAN JAVIER"
Km 10.5 Casilla No. 169 12A[]][56
Cochabamba, Bolivia 1/21/04
FEI# 3004145277
Planta Elaboradora de Queso San Javier S. aureus
"PEQ San Javier" and
Santa Cruz, Bolivia E. coli
FEI# 3004150168 1/30/04
DOMINICAN REPUBLIC (DO)
Martin Garcia Salmonella
Unknown Street and
Guayubin, Dominican Republic E. coli
FEI# 3004635162 8/12/04
MFR:
Ramon Vasquez E. coli
Luperon C/4 #68 S. aureus
Puerto Plata, Dominican Republic 4/22/04
FEI# 3004488339
SHIPPER:
Exportaciones Francisco Perez
Calle 5/No. 13, Villa de Buena Vista
Santiago, Domican Republic
FEI# 3004319744
EGYPT (EG)
FIRM: PROBLEM:
International Agencies Commerce E. coli
Ltd., Co.
6 Boutros Ghaly St.
Heliopolis, Egypt
FEI# 1000553739
MID# EGINTAGE6HEL
FRANCE (FR)
Fromageri Bouchet E. coli
Zi Juge Guerin 4/20/04
Beaumont, France
FEI# 3004293290
S.A.R.F. Entrammes, S.A. Port Salut Cheese
S.A. Fermiers Reunis Salmonella
Route de Nuille 5/Vicoin 12AGP52
53260 Entrammes, France 12AGP19
FEI #3003456314 8/20/02
GREECE (GR)
Hotos S.A. E. coli
10 Vlahava St. 400 11 Falani S. aureus
Larissa, Greece 4/20/04
EI# 3004291758
MFR:
S.H. M. Hellas S.A. E. coli
2nd Industrial Zone
P.O. Box 1153 8/5/04
Volos, Greece
FEI# 3004288253
SHIPPER:
Alwelis Weber Hndelsgesellschaft
2 Finkenwag
Altanstadt, Germany
FEI# 3003035126
HONDURAS (HN)
FIRM: PROBLEM:
Agroindustrias Las Penitas S. aureus
Juticalpa, Olancho, Honduras 6/25/04
FEI# 3003769278
EXOFRAM S. De R. L. Salmonella
(Exportadora Francisco Morazon) 4/20/04
Res. Centro American Este
4TA Etapa Bloque 88 Calle 34 No. 3
Tegucigalpa, Honduras
FEI# 3004328063
Importaciones y Exportaciones de E. coli
Honduras (IMPEX) S. aureus
Colonia Cero Grande Zona 4-B
40 Casa N. 3202 8/13/04
Comayaguela, Honduras
FEI# 3003556849
Industrias Lacteos Jutiquile E. coli, S. aureus
Olancho, Honduras 5/ /03
FEI# 3003752200
Lacteos de Honduras, S.A. de C.V. Salmonella,
(Lacthosa) S. aureus, E. coli
Barrio Bermejo, Blvd. de Norte, 4/4/03
Salida a Puerto Cortes
Apartado Postal No. 140
San Pedro Sula, Honduras
FEE# 1000382933
Leche Y Derivados S.A. S. aureus
Street address unknown 6/30/03
Honduras, Honduras
FEI #3003844724
Leches de Olanchito Salmonella,
Colonia el Triangulo salida E. coli,
A Coyoles Central S. aureus
Olanchito, Honduras 9/9/03
FEI #3004037346
Luis Alfreda Corrales Salmonella
San Marcos de of Colon E. coli
Choluteca, Honduras S. aureus
FEI# 3000287495
Mana Group S. aureus
Col. Bendeck 07/05/03
1 Calle 4 Ave Casa No. 434
El Progreso, Yoro, Honduras
FEI #3003241316
Maria Isabel Gonzalez Salmonella
Comayaguela Mdc 9/16/03
Tegucigalpa, Honduras
FEI #3004077195 E.Coli
10/22/03
Planta De Productor Salmonella
Lactose Lacor E. coli
Registro Sanitario 8579 S. aureus
Choluteca, Honduras
FEI# 3000287494
Productos Lacteos Telica S. aureus
Carretera a Catacamas Km. 11 7/24/03
Tegucigalpa, Honduras
FEI #3003988710
Productos Naver E. coli
Col. Cerro Grande S. aureus
Zona 4, Bioque 10 No. 8 10/18/04
Comayaguela, Honduras
FEI# 3004579787
Prolaca E.Coli and
Unknown address S.aureus
Olancho, Honduras 7/2/02
FEI #3001925125
Prolateh
Tegucigalpa, Honduras E. coli
FEI #3003529017 S. aureus
5/1/02
Roberto Belisle S.aureus
Barrio Cieneguita Salmonella
Puerto Cortez, Honduras 9/30/03
FEI# 3004017370
Rancho Isletas E. Coli and
Unknown address S. Aureus
Tegcigalpa, Honduras 7/2/02
FEI #3002882317
ITALY (IT)
FIRM: PROBLEM:
Occelli Agrinatura SRL E. coli
Regione Scarrone 7/24/03
Farigiliano, Italy
FEI #3002958687
MEXICO (MX)
FIRM: PROBLEM:
Alejandro Dorantes Munoz E. coli
26 Alurares S. aureus
Iguala, Mexico 10/10/03
FEI# 3003815702
Alprodel S.A. de C.V. S. Aureus
Privada Del Ceyland 4/4/03
Mexico D.F., Mexico
FEI# 3003092191
Cremeria Vero Interior Del Salmonella
Mercado Municipal S. aureus
Pasillo E Local 161 E. coli
Iguala, Mexico 10/14/03
FEI# 3003816149
Everado Rodriquez E. coli
Dom Conocido Col. Nvo 10/10/03
Morelosjesus
Veracruz, Meixco
FEI# 3003818116
Exportadora de Productos Mexicanos S. aureus
Colonia Aleman 3/2/04
N.512 Rancho San Martin
Las Choapas, Mexico
FEI# 3003861739
Jorge Fitz E. coli
Calle 16 de Septiembre S. aureus
Los Sauces Gro, Mexico 10/10/03
FEI# 3002804431
La Casa Del Buen Mole Salmonella
Emiliana Zapata #41 Col. E. coli
Emiliana Zapata 6/25/04
Teloloapan, MX
FEI# 3003239746 S. Aureus
7/22/04
Lacteos Guero Godinex Salmonella Group C
Ramon Corona #513A 12/3/02
Ciudad Guzman, Jalisco, Mexico
FEI #3003407510
Lacto productos La E. coli
Providencia S.A. de C.V. 10/10/03
KM 5 Carr Fed. Tex
San Ixtacuixtla, Mexico
FEI# 3003981237
Lactos Productos La Providencia E. coli
S.A. de C.V. 2/27/04
Kll 6 Carr Fed Tex
Tlaxcala, Mexico
FEI# 3004178133
Lactoes Rico, S.A. de C.V. S. aureus and
Dom. Conocido E. coli
Ozuluama, Veracruz, Mexico 2/10/04
FEEI# 3004108474
Monte Alban Ttes Productos E. coli
Alimenticios Naturales Y Mexico 10/10/03
Calzada Ing Juan Ojeda
Robles Santa
Tijuana, BC, Mexico
FEI #3001231069
Pedro Saveda S.aureus
Domicilio Concido Los Sauses E. Coli
Guerrero, Mexico Salmonella
FEI# 3001629447 9/30/03
Piedra Blanca Lacteos S. de R. L. De C.V. E. coli
Ave. Cristo Rey Oriente-B, Centro CP 91477 8/17/04
Palma Sola, Veracruz, Mexico
FEI# 3004694445
Productos De Leche San Martin E. coli
S.A. de C.V. 3/9/04
Tenochtitlan No. 20-C
Col. Santa Isabel, Tola
Mexico, D.F., Mexico
FEI# 3004308359
Productos Lacteos De Ozuluama Salmonella spp Poly A
Carretera Tuxpan-Tampico Group D2
Km 124, Ozuluama, 6/5/98
Mexico
FEI# 3001345298
Queseria Chila E. coli
Filomeno Mata #316 11/16/04
Col. Frente Democratico
Tampico, TAM, C.P. Mexico
FEI# 3004717434
Queseria Los Rosales,S.C. de E. coli
P. der L.DE 10/14/03
Col Patio de Rosas Campo 20
Mpio Santiago Papasquiraro
Durango, Mexico
FEI# 3003772770
Quesos Colima Sa De Salmonella
CV 3/23/04
Calle 15 #68
Co. Valentin Gomez Farias
DF CP 15010
Mexico
FEI# 3003625591
Roberto Hurtado Flores S. Aureus
14 Ejercito Trigaratne 11/18/02
Teloloapan, Guerrero, Mexico
FEI #3003244918
Sociedad Cooperativa De E. coli
Productos Queseria L 10/14/03
San Juan #30 Col San Juan
Nuevo Ideal Durango,R.F., Mexico
FEI# 3003617653
Victor Manual Mittolo Dussauge S. aureus
Ave Independenci #166 Col e Rquez E. coli
Tuxpan, Ver., Mexico Salmonella
FEI# 3003103617 10/22/03
NICARAGUA (NI)
FIRM: PROBLEM:
Agricorp S. aureus
Rotonda Centroamerica 308 Mis 4/20/04
Managua, Nicaragua
FEI# 3004448014
Cooperativa Agropecuaria y Salmonella, S.aureus,
Produccion Nicarao E. coli
(Cooperativa Nicarao) 11/18/02
Km 118 Carretera Panamericana Sur
Rivas, Nicaragua
FEI #3003757876
Dalia Productos Lacteos S. aureus
Matagalpa, Nicaragua E. coli
FEI# 3002958743 10/30/03
Fabrica de Productos Lactos E. coli
"La Perfecta" S.A. 03/1/01
Km 4 1/2 Carretera Norte, Apartado 1588
Managua, Nicaragua
FEI# 3003143244
Ganaderia San Roman S. aureus
46 Carretera A Biriamba 01/30/04
Carazo, Nicaragua
FEI# 3004176912
Industrias Ircasa S.A. E. coli and
Km 24 Carreta Nueva A S. aureus
Leon Hacienda 3/23/04
Managua, Nicaragua
FEI# 3004154871
Lactosam S. aureus
a.k.a. Lacteos Santa Martha 6/25/04
Salida Al Tumas, Las Piedrecitas
Matagalpa, Nicaragua
FEI# 3004108938
Masiguito, R.L. Staphyloccoccal enterotoxin
Unknown Street and S. aureus
Camoapa, Nicaragua 12/11/01
FEI #3003383795
Patricia Lopez Solano S. aureus
Col. Morazan D484 01/30/04
Managua, Nicaragua
FEI# 3003472315
Productos Lacteos El Truinfo E. coli
Calle Principal Al Municipio S. aureus
De El Almendro 4/20/04
El Almendro, Nicaragua
FEI# 3004253264
Productos Nicas Salmonella
Oscar Satana Rodriquez E. coli and
Managua, Nicaragua S. aureus
FEI# 3002896034 3/23/04
Queso Nica El Boxeador S. Aureus
Managua, Nicaragua 7/22/04
FEI# 3004605138
And
Productos Lacteos Matiguas
46 « Carretera A Diriamba
Matiguas, Nicaragua
FEI# 3004437941
Shipper:
Productos Nicas "Osacar Santana" Rodriquez
Fonif Dist. #5 « C. Al Sur
Managua, Nicaragua
FEI# 3002896034
DBA:
Productos Nica Oscar Santana Inc.
Mercado Roberto Huembes Modulo B-9
Managua, Nicaragua
FEI# 3004283189
PORTUGAL (PT)
FIRM: PROBLEM:
Cooperative Dairy Union of Lourais S. aureus
9850-261 Riberira Seca Cht. 5/3/01
St. Jorge, Azores, Portugal
FEI# 1000153617
VENEZUELA (VE)
Luis Tovar Chaivez E. coli and S. aureus
Ciudada Alianza & Etapa Manzana 15 #24 12/22/03
Valencia, Carabobo
Venezuela
FEI #3004101895