IA #16-120, 12/15/2000 - REVISION TO TEXT AND ATTACHMENT OF IMPORT ALERT #16-
120 "DETENTION WITHOUT PHYSICAL EXAMINATION OF FISH AND FISHERY PRODUCTS
WHERE THE FOREIGN PROCESSOR HAS FAILED TO COMPLY WITH SEAFOOD HACCP, 21 CFR
123", ATTACHMENT - 2/11/09
Revision of this import alert edits the text indicated by asterisks (***) and
adds foreign processors/products to the Attachment as recommended by
CFSAN/Office of Seafood, HFS-400
TYPE OF ALERT: Detention without Physical Examination
(Note: This import alert represents the Agency's current
guidance to FDA field personnel regarding verification
requirements of seafood HACCP as they pertain to foreign
processor(s) (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: See Attachment
PRODUCT CODE: See Attachment
PROBLEM: Failure of foreign processor(s) (manufacturer(s)) to comply
with requirements of 21 CFR 123, "Fish and Fishery Products"
(OASIS Charge Code - MFRHACCP)
PAF (Problem
Area Flag): REG
PAC FOR
COLLECTION: 03844 - Foodborne Biological Hazards
07844 - Natural Toxins
09844E - Color Additives
09844F - Food Additives
COUNTRY: See Attachment
MANUFACTURER
(FOREIGN PROCESSOR)
AND FEI: See Attachment
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to have been prepared,
packed, or held under insanitary conditions, or it may be
injurious to health, due to failure of the foreign processor
to comply with 21 CFR 123 [Adulteration, 402(a)(4)]."
(OASIS Charge Code - MFRHACCP)
RECOMMENDING
OFFICE: CFSAN, Office of Seafood, HFS-400
Division of Import Operations and Policy (HFC-170)REASON FOR
ALERT: On December 18, 1997, 21 CFR Part 123 became effective.
Under this regulation, all fish and fishery products,
whether foreign or domestic in origin, are required to be
prepared, packed and held in facilities operating under
mandatory HACCP requirements. ***Foreign processors who fail
to meet these requirements may have entries subject to
detention without physical examination until such time as
such documentation demonstrating compliance is provided, as
described in "GUIDANCE" section of this import alert.
*** FDA might determine the foreign processor's compliance
through inspection of the foreign processor, inspection of
an importer, review of import entry records, or through
review of an importer's seafood product reconditioning
proposal.
GUIDANCE: Districts may detain, without physical sampling and
analysis, fish and fishery products from foreign
processors(manufacturers) as noted on the Attachment to this
import alert.
***(Note: Districts should refer to Compliance Program
7303.0844, "Import Seafood Products" for implementation
guidance.
*** Districts should be aware that for inclusion to or
removal from detention without physical examination of
foreign processor/product combinations listed on the
Attachment to this import alert, the following procedures
apply:
*** When CFSAN's Office of Seafood has determined that a
foreign processor has failed to meet HACCP requirements for
a specific product, that Office may recommend that the
foreign processor/product(s) combination be subject to
detention without physical examination and included on the
Attachment to this import alert.
*** Foreign processors listed on the Attachment to this
import alert may be removed from the Attachment by
submitting documentation demonstrating that they are in
compliance with the seafood HACCP regulation (21 CFR, Part
123). The foreign processor should provide this
documentation to CFSAN's Office of Field Programs Import
Branch (HFS-606).
For questions regarding adequacy of foreign processor HACCP
documentation, contact CFSAN's Office of Seafood telephone
number: 202-418-3150, or Fax number: 202-418-3196.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: HACCP, foreign processor, fish, fishery product, seafood,
manufacturer
PREPARED BY: DIOP (Linda Wisniowski, Doug Randes),301-443-6553
CFSAN, OFP, (Frank Sikorsky, 202-205-1922
Brian Landesberg, 202-205-5247)
DATE LOADED
INTO FIARS: December 15, 2000
ATTACHMENT - 2/11/09
DETENTION WITHOUT PHYSICAL EXAMINATION FOR SPECIFIED COMBINATIONS OF FOREIGN
PROCESSORS AND FISH/FISHERY PRODUCTS
BRAZIL (BR)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Atlantica Marthino Ltda. Dried Sharks Fins 16Y--08 4/17/03
Rua Dona Arvelina
De Oliveira 387
Recife, Pernambuco
Brazil
FEI# 1000469697
Campasa Camarones Do Mahi Mahi Products 16A- -51 4/6/05
Para S/A
Povado De Sao Do Abade
S/N CX Postal 08
CEP 68.750-000
Curuca, Brazil
FEI# 3003181004
Frigorifico Calombe Fresh Fish Scombrotoxin 16A[][]01 4/1/05
Industria Species (whole and 16A[][]05
E Comercio Ltda. gutted) 16A[][]07
Ave Colombe 3010 16A[][]21
Rio De Janeiro, Brazil 16A[][]33
FEI# 3003854606 16A[][]37
16A[][]45
16A[][]51
16A[][]69
16A[][]70
16A[][]71
16A[][]73
16A[][]76
16A[][]78
16A[][]79
Mucuripe Pesca Ltda. Shrimp 16J[][]05 10/29/03
Rua Chile, 84
Ribeira, Natal, Brazil Tuna 16A[][]42 10/29/03
FEI# 3001721063
Mahi-Mahi 16A[][]51 10/29/03
Escolar 16A[][]69 10/29/03
Marlin 16A[][]54 10/29/03
Taiyo Industria De Pesca, Tuna 16A--45 8/8/03
Rua Otavio Correa, 115
Santos, Sao Paulo 11025-230, Mahi-Mahi 16A--51 8/8/03
Brazil
FEI# 3001683595 Marlin 16A--54 8/8/03
Escolar 16A--69 8/8/03
CANADA (CA)
FOREIGN PROCESSOR
NAME AND ADDRESS/
FEI NUMBER: PRODUCT: PRODUCT DATE:
CODE
Cap Pele Herring Export Inc. Bloaters Choice 16S[]P21 2/11/09
2661 M Chemin Acadie Smoked Herring
Cap-Pele, New Brunswick
Canada
FEI: 3005331590
CHINA (CN)
FOREIGN PROCESSOR
NAME AND ADDRESS/
FEI NUMBER: PRODUCT: PRODUCT DATE:
CODE:
Asian Seafoods (Zhanjiang) Frozen breaded shrimp 16J[][]05 12/10/08
Co., Ltd.. Frozen floured shrimp 16K[][]05
55 Yongping Road, Zhanjiang
Economic Zone, Guangdong
Zhanjiang, Cn-44 Cn
Fei# 3004279072
Changle Juquan Foods Co., Eel 16A[][]15 12/10/08
Liyushan, Heshang Town 16B[][]15
Changle City, Fujian CN 16C[][]15
FEI# 3004268890 16I[][]15
16S[][]15
16X[][]99
Fujian Longxiang Frozen Eel 16A[][]15 12/10/08
Aquatic Food Co.,Ltd. 16B[][]15
Paibian Village 16C[][]15
Shangjing Town 16I[][]15
Fuqing City, CN-35 CN 16S[][]15
Fei# 3004302391 16X[][]99
Fuqing Yihua Aquatic Food Co.,Ltd IQF frozen 16J[]N05 12/18/08
188 Longjin Road cooked shrimp
Fuqing City, Fujian, China
FEI# 3000197650
Shantou Manlian Co., Ltd. Eel 16A[][]15 12/10/08
No.61 Zhuchi Road, 16B[][]15
Shantou City, Guangdong, China 16C[][]15
Shantou, Cn-44 Cn 16I[][]15
Fei# 3004966670 16S[][]15
16X[][]99
Taishan Lvsheng Food Co.,Ltd. Eel 16A[][]15 12/10/08
Fushi Village Doushan Town, 16B[][]15
Guangdong,China 16C[][]15
Taishan, Cn-44 Cn 16I[][]15
Fei# 2000045473 16S[][]15
16X[][]99
Zhanjiang Evergreen Aquatic Breaded shrimp 16J[][]05 12/10/08
Product Frozen dusted shrimp 16K[][]05
Rui Yun Bd.N. Mazhang 16X[][]99
Zhanjiang, Cn-44 Cn
FEI# 3005342238
Zhanjiang Go-Harvest Aquatic IQF breaded shrimp 16J[][]05 12/10/08
Products Co., Ltd. Frozen floured shrimp 16K[][]05
Ruiyun Road N Mazhang District
Zhanjiang, Guangdong, China
ZHANJIANG, CN
FEI# 3004256789
Zhanjiang Longwei Aquatic Shrimp 16J[][]05 12/10/08
Products Ind. Co., Ltd.
Industrial Zone of Xiashan Huagang
Zhanjiang City, Guangdong CN
FEI# 2000041911
ECUADOR (EC)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Clarich S.A. Canned Sardines 16AEE33 2/20/04
Clda. Prosperina
Callejon, Iera 723Y
Guayaquil, Ecuador
FCE #10850
FEI# 3001048770
Escualem Cia Ltda. Cooked Stone Crab Claws 16J-N01 8/2/07
La Propicia #1
Esmeraldas
Ecuador
FEI# 3004184069
EL SALVADOR (SV)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Carlos Eusebio Moran All Seafood Products 16[][][] 2/9/04
(AKA Chevy Moran)
(AKA Atlactal Food)
Colonia Lorena
Calle Principal 7
San Ramon
San Salvador
El Salvador
FEI# 3000161718
San Marino S.A. de C.V. Fresh Frozen Shrimp 16J--05 1/16/04
Carretera El Litoral 16X--21
Kilometro #111.5 Oeste
Canton La Nueva
Sonsonate, El Salvador
FEI# 3004141573 Fresh and Fresh 16A--45 1/16/04
Frozen Tuna
ESTONIA (EE)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
AS Spratfil Ltd. Marinated Herring 16A[][]21 6/25/04
Lesta 14 Fillets 16I[][]21
13516 Tallinn 16S[][]21
Estonia
FEI# 3004153779 Sprat Fillets 16A[][]33 6/25/04
16I[][]33
16S[][]33
Viru Kalatoostuse OU Canned Sprats 16AEE33 4/26/04
Joe 12 Street
41702
Ida-Virumaa
Toila, Estonia
FCE# 12448
FEI# 3003463220
FIJI(FJ)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Cakaudrove Fish Spanish Mackerel and 16A[][]22 4/19/07
11 Bureta Street other Histamine forming 16A[][][]
P.O. Box 12120 fish species
Suva, Fiji
FEI# 2000019139
INDIA (IN)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Abad Fisheries Frozen Seafood Mix 16W[][]99 8/28/01
Abad Building 16W[][]22
P.O. Box No. 313 16Y[][]99
Cochin, Kerala, India
FEI# 3002692640
Phillips Foods India Pvt Ltd Frozen, CO treated 16AV[]45 05/22/06
C 75/76 Sipcot Industrial vacuum packed tuna
Madathoor, P.O. Tuticorin fish portions
India
FEI# 3003708108
Sea Fresh Exports Ltd. IQF Mackerel 16AD22 11/26/01
P. O. Box 9, Industrial 16AD73
Estate
Aroor - 688534
India IQF Anchovies 16AD01
FEI# 1000157236
IQF Seerfish 16AD99
INDONESIA (ID)
FOREIGN PROCESSOR
NAME AND ADDRESS/
FEI NUMBER: PRODUCT: PRODUCT CODE DATE:
Pt. Bitung Mina Utama Tuna 16A[][]45 12/18/08
Jl Aertembagan Lingkungan Ii Marlin 16A[][]54
Bitung Timur North Sulawesi Swordfish 16A[][]42
Indonesia
FEI# 3003617751
KOREA (KR)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Samhong Industrial Co.,Ltd Cooked Sandwich 16L01 11/30/01
1062 Hupo-Ri, Hupo-Myun Packed Crabmeat
Ulchin-Kun
Kyungbuk 767-830
South Korea
FEI# 3002341393
Sungjin Fishery Co. Ltd. Imitation crab
167-23 Manchun-dong meat stick 16R[][]02 05/1/01
Jinhae-City Imitation breaded
Kyungsangnam-do crab claw 16R[][]02 05/1/01
Korea, Republic of Imitation lobster
FEI# 3003109553 tail 16R[][]04 05/1/01
Imitation shrimp 16R[][]03 05/1/01
Other Imitation seafood
products, n.e.c 16R[][]99 05/1/01
Taerim Co., Ltd. Crab, Cooked 16J[]N01 1/8/02
1060 Hupo-Ri, Hupo-Myun, (in frozen blocks) 16J[]O01
Ulchin-gun
Kyung Buk 767-830, South Korea
FEI# 3003109559
LATVIA (LV)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
JSC Kaija Canned Sardines 16AEE33 2/11/04
15 Atlantijas St.
Riga, Latvia LV-1015
FCE# 10223
FEI# 3001687732 Canned Mackerel 16AEE73 2/11/04
Canned Herring 16AEE21 2/11/04
Sabiles Adk Ltd. All seafood products 16--- 5/14/02
20 Rigas St. Sabile
Talsi Region, Latvia
FEI# 3003282729
MALAYSIA (MY)
FIRM NAME/ADDRESS: PRODUCT PRODUCT DATE:
CODE OF DWPE
International Trading & All Seafood 16[][][][] 10/21/08
Manufacturing Co., 15,Solok Products
Indah 1 Taman Bukitindah,
Penang, Malaysia
FEI# 3004296982
PANAMA (PA)
FOREIGN PROCESSOR
NAME AND ADDRESS/
FEI NUMBER: PRODUCT: PRODUCT CODE DATE:
Isabella Seafood Corp. Mahi Mahi 16A[][]51 12/ /08
El Puerto de Boca de Parita Ave
Chitre, Panama
FEI# 3004326904
Salva-Mar Mahi Mahi 16A[][]51 1/9/09
Calle el Puerto
Puerto de Boca Parita
Monagrillo, Chitre, Panama
FEI # 3004261900
FEI # 2000027744
MEXICO (MX)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Expormar S.A. de C.V. Fresh Cooked Crabmeat 16J[][]01 1/12/07
Domicilio Conocido La Playita
Poste #37
La Reforma Angostura
Sinaloa 81680
Mexico
FEI# 3003519054
Industrializadora de Amberjack 16A[][]79 2/15/06
Pescados y Mariscos, S.A.
Calle 33 #247 X 8 y 10 Col.
Santa Maria King (Spanish) Mackerel 16A[][]22 2/15/06
Merida, Yucatan, Mexico 16A[][]73
FEI# 3005058855
3004969543 Grouper/Red Grouper 16A[][]17 2/15/06
Black Grouper
Snapper 16A[][]37 2/15/06
Intermarketing de Mexico All scombrotoxin 16A[][][][] 9/4/08
S.A. de C.V. forming fish species
Calle 10 #235 Parque
Industrial Fondeport
El Sauzal, Ensenada, B.C.
Mexico
FEI# 3004389747
Marlin Y Atun Ahumado Vacuum Packed 16SGP45 6/19/01
"Dona Jovita" Smoked Tuna 16SVP45
Carretera Internacional
Al Sur No. 467
Ejido El Castillo
Mazatlan, Sin.
Mexico
FEI# 3003269900
PERU (PE)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
GAM Corp. S.A. Mahi Mahi 16A[][]51 5/17/07
Calle Carbono No. 151
Urb. La Grimanesa
Callao 1, Peru
FEI# 3005075978
Maquimar S.A. Canned Achovies 16A- -01 4/7/04
Pasaje Don Oscar No. 150 in tomato Sauce
Acapulco (labeled as Sardines)
Callao
Peru
FEI# 3004189177
PHILIPPINES (PH)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
SMI Fish Industries, Inc. Frozen Raw Shrimp 16X[ ]D21 12/18/00
2614 Suez Street Corner (aquaculture) 16X[ ]T21 12/18/00
Kakarong
Makati City, Metro Manila,
Philippines
FEI# 1000167509
POLAND (PL)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Superfish S.A. Lightly salted
Kukinia 43 herring 16A[][]21 10/29/03
78-111 Ustronie Morskie
Poland
FEI# 3001125743
SINGAPORE (SG)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Leong Hin Foodstuff Cooked Surimi Products 16R---- 7/22/04
Supplier (PTE), Ltd.
18 Woodlands Terrace
Singapore 738443
FEI# 3003718621
SOUTH AFRICA (ZA)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Commercial Cold Storage Tuna 16A--45 11/21/01
Duncan Road, Duncan Dock
Port of Cape Town 8001
South Africa
FEI# 3003093336
Dried Ocean Products Dried Abalone 16E[][]01 1/2/04
9 Mykonos Pier Street 16E[][]09
Plot #4, Shed 1 16F[][]01
Airport Company 16F[][]09
Port Elizabeth 16G[][]01
South Africa 16G[][]09
FEI# 3002620032 16O[][]01
16T[][]01
16T[][]09
Kaytrad Commodities (Pty) Ltd. Tuna 16A[][]45 4/29/02
Yorke Pointe Rd.
P.O. Box 6501
Cape Town, South Africa
FEI# 1000588616
SURINAM (SR)
FIRM NAME AND ADDRESS PRODUCT PRODUCT DATE
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Suriname Sea Catch N.V. Fresh-on-ice 16A[]C[] 5/10/05
Industrie Terrein & fresh frozen 16A[]D[]
Saramaccadoorsteek.37 Scobrotoxin forming
Paramaribo, Surinam Species
FEI# 1000361995
FEI# 3004662659
Unity N.V. All Histamine 16[][][][] 5/27/05
AKA (Surefish Industrial) Producing Fish
Stiviweg Industrie Hal
Livorno, Paramaribo
Suriname
FEI# 1000155556
THAILAND (TH)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Chonburi LC Company Ltd. Dried Anchovies 16A[]H01 06/30/06
44/6 M.1 T Nhongmaidaeng
Chonburi, Thailand
FEI# 3004591897
Green Giant Ltd. Dried Anchovy 16A[]H01 06/19/06
19/7 Moo 15, Tapa
Ratchaburi, Thailand
FEI#3003564189
Hong Shun Fishery Co., Ltd Frozen yellow fin tuna 16A[][]45 06/19/06
64/125 Moo 7 Hatchasada
Muang, Thailand
FEI# 3003896408
Saigon International 2004 LLC Fermented Anchovy 16Y[][]09 4/25/08
113 Moo 9 Paengpuey Subdivision Sauce
Damnernsaduak (Mam Nem)
Ratchaburi 70130
Thailand
FEI# 3006309492
SJ Supreme Crispy Anchovy 16A[][]01 6/17/08
30/76 SOI 49, Rama 2 Rd. snacks 16B[][]01
Thakarm, Bangkunthie (sesame and chili 16C[][]01
Thailand,10150 flavors)
FEI# 3005119297
TRINIDAD & TOBAGO (TT)
FIRM NAME/ADDRESS: PRODUCT PRODUCT DATE
CODE OF DWPE
Oceanside and Fish Center Tuna 16A[][]45 1/9/09
193 Western Main Road
Chaguaramas, Trinidad & Tobago
FEI # 3004313130
Silva Hook Exports Tuna 16A[][]45 1/9/09
National Fisheries Compound
Production Ave., Sea Lots
Port of Spain, Trinidad & Tobago
FEI # 3004805982
VENEZUELA (VE)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Fresco Mar C.A. Shrimp, frozen, raw 16J[]D05 12/19/01
Calle Ortiz 16X[]D21 Revised
Sector Chamoturo 12/31/02
Baca de Pozo
Peninsula de Macanao
Isla de Margarita, Venezuela
FEI# 3002822141
VIETNAM (VN)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Camranh Seafoods Dried Anchovy 12/16/05 16A[]H01
60 Nguyen Thai Hoc Ba Ngoi
Camranh, Vietnam
FEI# 3003340386
Nam Hai Co., Ltd. Frozen Steamed 16A[][]73 10/16/03
279A Kinh Duong Vuong Street Mackerel
An Lac Ward, Binh
Chanh District
Ho Chi Minh City, Vietnam
FEI# 1000348363
Vung Tau Catching Fishery Frozen Mackerel 16A[][]73 7/14/05
and Service Corporation 16S[][]22
(VCS Corp)
191 Nguyen Thai Hoc St. Frozen Cooked Clam 16E[[[]02 7/14/05
District 01
Ho Chi Minh City, Vietnam
FEI# 1000279949 Cream fish 16A[][]65 7/14/05
(Meuschenia scaber) 16A[][]56
aka "Triggerfish"
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