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 - 11/1/04
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 and 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, and
CFSAN, OFP, (Frank Sikorsky, 202-205-1922; Brian Landesberg,
202-205-5247)
DATE LOADED
INTO FIARS: December 15, 2000
ATTACHMENT - 11/1/04
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
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
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
Fishing Corp. S.A. Tuna 16A- -45 3/3/04
KM 22 Via a la Costa
Guayaquil, Ecuador
FEI #3004144737 Sardines 16A- -33
Frigolab "San Mateo" Fresh/Frozen Scombrotoxin 16A--45 11/1/04
Via San Mateo Km. 4 1/2 species/ 16A- 51
Manta, Ecuador 16A -54
1000156635 16A -69
16A -78
16A--79
Frigolandia S.A. Fresh & Frozen Scombrotoxin 16A- -45 9/21/04
Km 9« via a Daule forming SpecieS 16A- -51
Guayaquil, Ecuador 16A- -54
FEI #1000476279 16A -69
16A -78
16A -79
Mardex Cia Ltd Vacuum Packed 16AVC45 01/18/01
Avenida 102 Fresh Tuna 16AVD45 01/18/01
Los Enteros 16AVT45 01/18/01
Casilla (POB) 13053894
Manta, Ecuador (Manabi)
FEI #1000002613
Vacuum Packed
Fresh Red Snapper 16AVC37 01/18/01
16AVD37 01/18/01
16AVT37 01/18/01
Vacuum Packed
Fresh Grouper 16AVC17 01/18/01
16AVD17 01/18/01
16AVT17 01/18/01
Vacuum Packed
Fresh Mahi Mahi 16AVC51 01/18/01
16AVD51 01/18/01
16AVT51 01/18/01
Vacuum Packed
Fresh Marlin 16AVC54 01/18/01
16AVD54 01/18/01
16AVT54 01/18/01
Promarosa Cia., Ltda. Fresh Mahi-Mahi Fillets 16A--51 11/1/04
Calle 59 entre Avenida Fresh Blue Marlin Lions 16A--54
49 y 50 Santa Rosa Fresh Silver Corvina 16A -55
Sector Carnitas Fillets
Salinas, Ecuador
FEI #13376
EL SALVADOR (SV)
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
Carretera El Litoral 16J--05
Kilometro #111.5 Oeste 16X--21
Canton La Nueva 1/16/04
Sonsonate, El Salvador
FEI# 3004141573 Fresh and Fresh Frozen Tuna
16A--45
1/16/04
ESTONIA (EE)
FIRM NAME/ADDRESS PRODUCT/PRODUCT CODE
AS Spratfil Ltd. Marinated Herring Fillets
Lesta 14 16A[][]21
13516 Tallinn 16I[][]21
Estonia 16S[][]21
FEI# 3004153779 6/25/04
Sprat Fillets
16A[][]33
16I[][]33
16S[][]33
6/25/04
Viru Kalatoostuse OU Canned Sprats 16AEE33 4/26/04
Joe 12 Street
41702
Ida-Virumaa
Toila, Estonia
FCE #12448
FEI# 3003463220
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
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
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:
Gamma-a SIA Canned Sardines 7/19/04
15/17 Audupes Street Canned Sprats 16A E E 33
Riga Latvia LV-1030 Canned Mackerel 16A E E 73
FEI #3003482333 Canned Herring 16A E E 21
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
MEXICO (MX)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Comercializadora Albino Frozen Block shrimp 16J--05 11/1/04
S.A. de C.V. 16X--21
Pto Salina Cruz
Lote 1-A, Planta Baja
Parque Industrial
Alfredo V. Bonfil
Mazatian, Sinaloa
Mexico
FEI# 3003192322
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
Pescados Indusrializados S.A. Canned tuna 16AEE42 8/24/04
De C.V. (PINSA)
Avenida Puerto de Mazatlan #406
Parque Industrial Alfredo V. Bonfil
Mazatlan, Sinaloa, Mexico
FEI# 3004269774
PANAMA (PA)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Isex Exportacion S.A. Frozen Raw Shrimp 16J[][]05 4/6/04
Avenida Balboa Edificio 16X[][]21
Balboa Plaz
Panama City
Panama
FEI #3003545957
PERU (PE)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
Agropecuaria Esmeralds Mahi-Mahi 16A--51 9/21/04
Panamericana SurKm. 18.5
Chorrillos, Lima 09
Peru
FEI #3002983740
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
Seafrost S.A.C. Mahi Mahi 16A--51 10/21/04
Carr. Paita Sullana
Manzanna B, Lote 1
Paita, Piura
Peru
FEI# 3002802132
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
Li Chuan Food Products Cooked Frozen Surimi 16[][][][] 9/7/04
(Pte) Ltd. Based Seafood Products
No. 40 Woodlands Terrace
Singapore 738456
FEI# 3004506089
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
TAIWAN (TW)
FIRM NAME AND ADDRESS PRODUCT PRODUCT DATE OF
CODE DWPE
Huang Chi Frozen Food Tilapia 16A--58 11/1/04
Factory Co., Ltd. Milkfish 16A--53
No. 21 Yu Kang Southern Catfish Fillets 16A--10
Kaoshiung, Taiwan, R.P.C. 16A--67
FEI# 3003501216 16X--02
Northwest Foods Ind. Co., Ltd. Surimi Based Frozen 16R--99 9/28/04
No. 15 Feen Liau Road Fish Paste with 16Y--03
Industrial 2nd District Cuttlefish
Taipei, Taiwan
FEI# 3003481193
THAILAND (TH)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS: CODE: of DWPE:
Phillips Seafood Pasteurized crabmeat 16J[][]01 9/15/04
(Thailand) Co.,Ltd. in metal cans and
61/9 Moo 1 Ratanakosin plastic containers;
200 Years Road All styles of crab
Ranong, 85000, Thailand meat
FEI# 1000555453
TRINIDAD & TOBAGO (TT)
FOREIGN PROCESSOR PRODUCT: PRODUCT DATE
NAME AND ADDRESS/ CODE: of DWPE:
FEI NUMBER:
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 12/31/02
Sector Chamoturo
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:
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