IA #16-105, ------REVISED 06/04/96, ATTACHMENT REVISED 1/12/09
NOTE: This alert has been revised to incorporate uniform guidance for
decomposition, revise references to the CPG, and to update the
format. This revision incorporates firms and products covered by
Import Alert #16-38, "Automatic Detention of Shrimp Due to
Decomposition" and 16-41, "Automatic Detention and Increased
Surveillance of Scallops Due to Decomposition." Upon issuance of
this revision, Import Alerts #16-38 and 16-41 are cancelled.
Additional changes are bracketed by asterisks().
SUBJECT: "Automatic Detention of Seafood and Seafood Products from
Specific Manufacturers/Shippers Due to Decomposition and/or
Histamines"
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert contains guidance to FDA field
personnel only. It does not establish any requirements or
create any rights or obligations on FDA or on regulated
entities.)
PRODUCT: Seafood and seafood products, except:
-Mahimahi covered under Import Alert #16-05;
-Shrimp covered under Import Alerts #16-18 and 16-35.
-Canned shrimp from Thailand covered under Import Alert
#16-22;
-Canned tuna covered under Import Alert #16-95
PRODUCT CODE: See attachment
PROBLEM: Decomposition (MSDC)
Histamines (FLHS)
PAC: 03844
COUNTRY: See attachment
MFG/
SHIPPER: See attachment
MFG/
SHIPPERS ID#: See attachment
CHARGE: For decomposition:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to consist in whole or
in part of a decomposed substance, or to be otherwise unfit
for food [Adulteration, Section 402(a)(3)]."
or
For histamine:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to bear or contain
histamine, a poisonous and deleterious substance in such
quantity as ordinarily renders it injurious to health,
[Adulteration, Section 402(a)(1)]."
RECOMMENDING
OFFICE: Division of Import Operations and Policy (HFC-170)
REASON FOR
ALERT: DIOP has received recommendations from districts for
detention without physical examination of seafood and
seafood products from specific manufacturers/shippers due to
decomposition. This import alert has been developed for
manufacturers and shippers of decomposed seafood products
and products that contain histamines that meet the criteria
for detention without physical examination and cannot
readily be included in previously existing alerts.
Since early May 1992, the Agency has noted several separate
outbreaks of scrombroid poisoning attributed to fresh or
frozen tuna. The most recent outbreak occurred in Florida
and was traced to frozen tuna packed by a firm in Taiwan.
GUIDANCE: Districts may detain, without physical examination,
shipments of the specified products from the firms
identified on the attachment to this alert.
Surveillance sampling of all shrimp and scallop shipments is
warranted.
When districts encounter multiple violative shipments of
seafood products for decomposition, detected
organoleptically or as indole or histamines from the same
manufacturer or shipper, a recommendation for detention
without physical examination should be forwarded to DIOP.
DIOP, in turn, will coordinate with CFSAN.
Compliance Policy Guide (CPG)540.575 contains guidance for
evaluating decomposition in fish.
Refer to Compliance Program CP 7303.844 - Import Seafood
Products for sample collection guidance and instructions on
methodology for histamine or indole analysis.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required.
KEYWORDS: Decomposition, histamine, indole, seafood, crabmeat, fish,
shrimp
PREPARED BY: Ted Poplawski, DIOP (301) 443-6553
DATE LOADED
INTO FIARS: June 4, 1996
ATTACHMENT IA #16-105 REVISED 1/12/09
FIRMS/PRODUCTS ON DETENTION WITHOUT PHYSICAL EXAMINATION
CHILE (CL, 275)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Antarfish Sociedad Fresh & frozen 12/2/93 16E[]A05 Decomposition
Anonima scallops
Moneda 920 OF. 205-206
Santiago, Chile
MID# CLANTSOC2052SAN
FEI# 1000145352
Pesquera Santa Frozen Whiting 8/19/94 16A[]G49 Decomposition
Lucia S.A. Fresh Whiting
Casilla 131
Quintero, Chile
MID# CLPESSAN131QUI
FEI# 1000128361
Productos Marinos Fresh & frozen 8/19/94 16E[]A05 Decomposition
Del Norte scallops
Gallo 395
Caldera, Chile
MID# CLPOMAR395CAL
FEI# 1000208181
CHINA (CN)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Zhejiang Zhongda Xinli Trading Frozen IQF 3/1/01 16J[][]05
Co. Ltd. Shrimp 16X[][]21
No 11f Tower A, Zhongda Plaza
Hangzhou, China
FEI# 3003040003
ECUADOR (EC, 325)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Bajaspec S.A. Fresh, Fresh Frozen 7/12/01 16A-D69 Histamines
aka Escolar
Especies de Bajamamar
Cdla Adace Mz
113 b Calle 5 ta
Guayaquil, Ecuador
FEI# 13428
Crimaxi S.A. Fresh, Fresh Frozen 7/13/01 16A-D69 Histamines
Santa Cecilia Escolar
Mz Xa Solar 14
Guayaquil, Ecuador
FEI# 3003024904
Estemar S.A. Fresh & fresh 6/24/87 16J[][]05 Decomposition
aka Stella Maris frozen shrimp
Guayaquil, Ecuador
MID# ECESTSAGUA
FEI# 190
Marco Marchan Fresh, Fresh Frozen 7/13/01 16A-D69 Histamines
Fresh Fish Analore S.A. Escolar
Calle 14 y Ave.21
Manta, Ecuador
FEI# 3002769771
Pefresman Cia. Ltda. Fresh/Fresh 7/29/97 16A--54 Histamine
Calle 113, Avenida 103 Marlin Loins
Manta, Ecuador
FEI# 13375
Promarosa Fresh, Fresh Frozen 9/26/02 16A 69 Histamines
(Productos del Mar Santa Escolar
Rosa Cia. Ltda.)
Manzana No. 14
Santa Rosa, Salinas
Ecuador
FEI #1000155732
OFFICE
Promarosa
(Productos del Mar Santa Rosa Cia. Ltda.)
10 de Augosto 103 y Malecon P.B. OFC.11
Guayaquil, Ecuador
FEI #3000181496
GUYANA (GY, 418)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Tropical Products Fresh & fresh 8/30/93 16J[][]05 Decomposition
(Guy), Ltd. frozen shrimp
Lot 41 Boyle Place
Stabroek
Georgetown, Guyana
MID# GYTROPRO41GEO
FEI# 1000134187
INDONESIA (ID, 458)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Cv Puri Rasa Food Frozen yellow- 12/21/01 16A--45 Decomposition
Industry fin tuna fillet
Br. Carik Padang,
Desa Nyambu
Tabanan, Indonesia
FEI# 1000151855
Pt. Arabikatama Tuna, frozen 11/29/06 Histamines
Khatulistiwa Fishing 16A[][]45
Industry
Jl. By Pass Ngurah
Rai No. 92XX
Pesanggrahan,
Denpasar, Indonesia
FEI # 3004276277
P.T. Damarina Sumber Bahari All Tuna Products Histamine
J1 Ikan Tuna Raya No.19 16A -45
Pelbenoa Denpasar
Bali, Indonesia, 80222 12/17/04
FEI# 3004170448
PT. Dharma Samudera Scarlet Snapper 2/2/06 16A[][]37 Decomposition
Fishing Industries
Jl. Laks. R.E. Frozen Tuna 3/27/07 16A[][]45 Histamines
Martadinata 1
Tanjung Priok
Jakarta, Indonesia
FEI# 3004129247
Pt. Fajar Insan Nusantara Frozen Tuna 4/29/02 16A[][]45 Decomposition
Jl Pejompongan
Dajam No. 5
Jakarta, Indonesia
FEI #3002952831
Pt. Hatindo Makmur Tuna 12/18/08 16A[][]45 Decomposition
Jl Ikan Tuna III
No. 2 Benoa
Denpasar, Bali
Indonesia
FEI# 2000045703
Pt. Lautan Murti Tuna Products 1/29/02 16A[][]45
JL. Lingkar Timur No. 23 Cliacap
Jawa Tengah, 52313, Indonesia
FEI# 3003399879
PT. Mandhaga Wiratama Frozen Raw Tuna 11/5/01 16A--45 Decomposition
Jl Cempaka Putih Tengah &
17 Blok F5 No. 34 Histamines
Jakarta Pusat Frozen Smoked/carbon 11/5/01 16S--45
Indonesia monoxide treated
FEI# 3002924671 Tuna Products
PT. Meka Permata Rejeki Frozen Tuna 10/11/07 Histamines
Jl. Ikan Tuna Raya No. 17 16A--45
Benoa, Denpasar
Bali, Indonesia
FEI# 2000044392
3005150442
JAPAN (JP)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Sankyo Food Kogyo Co., Ltd. 8/13/01 Frozen Shrimp Decomposition
Tokiwa Bldg., 3-8 16J--05
Tsukiji 4 Chome 16X--21
Chu-Ku, Tokyo
Japan
FEI# 14102
MEXICO (MX, 595)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Baja Blue Foods de Cooked claw 5/9/03 16J[]T01 Decomposition
Mexico SA de CV crab meat 16J[]N01
Calle Durango S/N
Frente Esc. Primaria
Puerto Penasco
Sonora, Mexico
FEI# 3003813448
Crown Crab Company Pasteurized 7/25/95 16J[]G01 Decomposition
Calle 63, No. 15 Claw Crabmeat
Ciudad del Carmen
Campeche, Mexico
MID# MXCROCRA63CIU
FEI# 1000382750
Jose Tiburcio Frozen 10/7/94 16J[]G01 Decomposition
Otero Diaz Infante Crabmeat
Calle Norte 805, Fracc.
Villa California Ciudad
Obregon, Sonora, Mexico
MID #MXJOSTIB8050BR
FEI# 1000153625
Juan Ramon Ganem Vargas Oilfish 4/24/08 16A[][]99 Decomposition
Domicilio Conocido Km. 7.5 &
Carretera Tuxpan-La Barra Norte S/N Histamines
La Barra, C.P. 92773, Tuxpan
Veracruz, Mexico
FEI# 3006138524
MYANMAR (MM)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Myint Myat Hein Shrimp, frozen 11/19/03 16J -05 Decomposition
Trading Co., Ltd. 16X- -21
No.23(B)Kwin Kyaung Rd.
Ahlone T/S
Yangon, Myanmar
FEI # 3003684537
PAKISTAN (PK, 700)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Seapak Enterprises Fresh & fresh 8/30/93 16J[][]05 Decomposition
8-3 Fish Harbour frozen shrimp
W. Wharf
Karachi, Pakistan
MID# PKSEAENT83KAR
FEI# 1000455473
PERU (PE, 720)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Acuicola, S.A. Fresh & frozen 4/27/93 16E[]A05 Decomposition
Av. Las Gladiolus S/N scallops
Urbanizacion Castilla
Piura, Peru
MID# PEACUSAPIU
FEI# 1000133615
Administration Fresh & frozen 10/17/95 16E[]A05 Decomposition
General De Servicios scallops
(ADGESA) S.A.
General Borgono 309-201
Pueblo Libre, Lima 21, Peru
MID# PEADG309LIM
FEI# 1000375982
Ransanos S.A. Fresh & frozen 4/27/93 16E[]A05 Decomposition
El Prado 482 scallops
Lima, Peru
MID# PERANSA482LIM
FEI# 1000131559
Sur Pesca, S.A. Fresh & frozen 4/27/93 16E[]A05 Decomposition
Colon 311 Miraflores scallops
Lima, Peru
MID# PESURPES311LIM
FEI# 1000133614
PHILIPPINES (PH, 725)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Adelmar Marine Porudcts Tuna Cubes 6/5/02 16A[][]45 Histamines
Trading Corp Frozen
9749 Santan Street
Vitalez Compound, Baltao
Paranaque, Metro Manila,
Philippines
FEI #3003560632
Alyanna Enterprises Dried Herring 1/13/04 16A- -21 Histamines
#2 Mulawin Street (AKA Dried Tuyo)
Town & Country
Executive Village
Marcos Hi-Way
Antipolo
PHILIPPINES
FEI# 3004095862
Amor Nino International Dried Herring, 8/7/03 16A- -21 Histamines
Trading Inc. frozen
Taguiporo, Sta. Ignacia
Tarlac, Philippines Dried Mackerel,8/7/03 16A- -73 Histamines
FEI # 1000443882 frozen 16A- -22
Edlou Enterprises Dried Mackerel 8/20/03 Histamines
341 Constancia Street 16A-H73
Manila, Philippines
FEI# 3003542896
Fitrite Inc. Smoked Herring 12/16/05 Histamines
145 Gen. Evangelista St. (Sea-Herring)
Extension 16I[][]21
Caloocan City 16S[][]21
Philippines
FEI# 3004262563
Mendoza Industries Dried Herring (Sardines) 12/18/02 Histamines
D'Beach Siyacab in Corn Oil and
Dipolog City 16A- - 21 Decomposition
Philippines 16A- - 33
FEI #3002668757
Star Exports Dried Herring 7/10/03 16A--21 Histamines
3 Kanduli Street Products
Silvina Village
Novaliches, Quezon City
Philippines
FEI# 3002838256
SPAIN(SP)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Albaladejo Hermanos, S.A. Salt Cured Tuna 2/1/07 16A- -45 Decomposition
Los Saez, 2 Products and
30748 San Pedro de Pinatar Histamines
Murcia, Spain
FEI# 2000013041
TAIWAN (TW)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Ching Yi Cheng Frozen Slipper Decomposition
Industrial Co., Ltd. Lobster Tails
Mfg. # 7F3 0083 and Meat
No. 6 Chang Tai St. 16J -08
Kaohsiung, Taiwan 4/16/03
FEI# 3003070527
MANUFACTURER
Fa Tai Frozen Food Works Frozen Slipper 3/3/06 Decomposition
No. 3, Hsing Yu 4th Road Lobster Tails
Chien-Chen District (Brown Shell)
Kaohsiung, Taiwan 16J{}{}04
FEI# 3004826355 16J{}{}08
3003619523
SHIPPERS
Forever Frozen Seafoods
6F, No. 8, 41 Lane, Hsin-Chia Rd.
Feng Shan City
Kaohsiung, Hsien, Taiwan
FEI# 3004328585
Interwave Company
4th Floor, No. 385-3,
Wan Ta Road
Taipei, Taiwan
FEI# 3002789137
Hochico Marine Processing Frozen Slipper Decomposition
Corp. Lobster Tails
29, Der Shin 1st Road and Meat
SU-AO, I-LAN
Taiwan 16J--08
FEI# 3002808707 8/5/04
THAILAND (TH)
FIRM NAME PRODUCT/PC DATE REASON
LI-Thai Frozen Foods Co., Ltd. Frozen Slipper 12/27/05 Decompositio
n
428/a Mu I Tambon Pakpoon Lobster
Muang Nakonsritammarat 16J[][]08
Thailand
FEI# 3002800381
Sethachon Company Frozen Steamed 11/21/05 Histamines
225 Moo 12, Teparak Rd. Mackerel
Bangpli Yai, Bangpli 16A[][]22
Samut Prakan 16A[][]73
Thailand
FEI# 1000324312
VENEZUELA (VE,940)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Comercializadora de Crabmeat, 9/12/07 16J[][]01 Decomposition
Productos Marinos Pasteurized
aka Compromar Unpasteurized
Calle 10, Ub.San Miguel
Local 16-67
Maracaibo
Zulia, Venezuela
FEI# 2000014539
Todamar S.A. Pasteurized 7/28/95 16J[]G01 Decomposition
Avenia San Francisco Canned
No. 131-443, 1 Crabmeat
Maracaibo, Venezuela
MID# VETODSA1314MAR
FEI# 1000181104
VIETNAM (VT)
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
Hai Vuong Co., Ltd. All Tuna Products Histamines &
Lot B, No. 1 St. 16A -- 45
Suoi Dau Industrial Zone 6/23/04 Decomposition
Khanh Hoa Province
Vietnam
FEI #3004277224
Kien Giang Ltd. Pangasius 09/16/05 Decomposition
80/18A Ba Huyen Thanh Quan, Bocourti Dist.
3, Ho Chi Minh City Fillets
Vietnam 16A[][]82/
FEI# 3003978428 16X[][]43
My Thanh Co., Ltd. All Mackerel 10/18/02 16A[][]22 Histamines
B1/16a Quoc Lo 1 Products 16A[][]73 & Decomposition
Binh Chanh Dist.
Ho Chi Minh City
Vietnam
FEI #3001224437
T & N Co. Ltd. Frozen 9/14/05 16A[][]45 Histamines
57 Hong Bang Street Tuna Steaks
Nha Tran City,
Khanh Hoa Province
Vietnam
FEI# 3004796935
Tin Thinh Co. Ltd. Frozen Tuna 03/2/05 16A[][]45 Histamines
80B, 23 Thang 10 St.
Nha Trang City,
Vietnam
FEI # 3003849326
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