Import Alert 16-127
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).
Import Alert # 16-127
Published Date: 04/15/2013
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Crabmeat Due to Chloramphenicol"
Reason for Alert:
Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals in the United States (U.S.).
Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia.
Since these adverse reactions are idiosyncratic and are not dose related, no one has yet been able to determine a safe level of exposure to chloramphenicol.
Chloramphenicol is suspected to be a carcinogen and may potentially affect the reproductive system in humans.
Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia.
Since these adverse reactions are idiosyncratic and are not dose related, no one has yet been able to determine a safe level of exposure to chloramphenicol.
Chloramphenicol is suspected to be a carcinogen and may potentially affect the reproductive system in humans.
Guidance:
Districts may detain, without physical examination (DWPE), the products from the firms identified in the Red List to this alert.
For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Crabmeat
Charge:
"The article is subject to refusal of admission, pursuant to Section 801(a)(3) in that it appears to be adulterated in that it bears or contains a poisonous or deleterious substance, namely, chloramphenicol, which may render it injurious to health, which is in violation of Section 402(a)(1)."
OASIS charge code - POIS CHLOR
AND
"The article is subject to refusal of admission, pursuant to Section 801(a)(3) in that it appears to be adulterated in that it bears or contains a food additive, namely, chloramphenicol, that is unsafe within the meaning of section 409, which is in violation of Section 402(a)(2)(C)(i)."
OASIS charge code - CHLORAMP
OASIS charge code - POIS CHLOR
AND
"The article is subject to refusal of admission, pursuant to Section 801(a)(3) in that it appears to be adulterated in that it bears or contains a food additive, namely, chloramphenicol, that is unsafe within the meaning of section 409, which is in violation of Section 402(a)(2)(C)(i)."
OASIS charge code - CHLORAMP
BRAZIL
Juncao Inc. Com. De Pescados Ltda.
Date Published : 09/16/2009
Rua Jose Bonifacio, 214 , Bairro Junc , Rio Grande, RS BRAZIL
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 10/18/2006
CHINA
Aquastar Food Shanghai Co. Ltd.
Date Published : 09/16/2009
152 Bei Zhao Jia Zhai , Cailu , Pudong, Cn-31 CHINA
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 1/24/2008
Dongshan Rong Feng Food Co, Ltd
Date Published : 01/04/2012
Dongshan Economic Development Zone. , Dongshan County, Fujian Province, China , Zhangzhou, CN-35 CHINA
16 J - - 01 Crab
Date Published: 01/04/2012
Desc:Crab Meat
LONGHAI GELIN FOODS CO., LTD
Date Published : 09/16/2009
Gangwei Town,longhai,fujian,china , LONGHAI, CN-35 CHINA
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 3/11/2004
The Freezing Plant Of Guangdong Shantouaquatic Products Imp/
Date Published : 09/16/2009
322 Anping Road , Shantou, CHINA
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 1/27/2003
Xiamen Liangfa Imp & Exp Trade Co.
Date Published : 09/16/2009
No. 87 Dongdu Rd. , Xiamen, CHINA
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 3/11/2003
INDONESIA
CV. Sira Guna Putra
Date Published : 09/16/2009
Jl. Pulau Solor (KIM II) , Medan, ID-SU INDONESIA
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 6/27/2008
P.T. Phillips Seafood Indonesia, Sulawesi Plant
Date Published : 10/16/2012
Jl. Lamelleng No. 42- KM. 147 Bojo Barru , Kec. Mallusetasi, Barru , Barru, ID-SN INDONESIA
16 J - - 01 Crab
Date Published: 10/16/2012
Desc:Canned Pasteurized Crab Claw Meat
PT. PANJI SABURAI PUTRA
Date Published : 09/16/2009
Jl. Raya Tanjung Bintang No. 99 , Desa Serdang Kec. Tj. Bintang , Lampung Selatan, INDONESIA
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 10/16/2006
PT. Phillips Seafoods Indonesia, Pemalang
Date Published : 04/01/2013
Dukuh Pejarakan Desa Danasari , Jl. Laks. Yos Sudarso NO 1 Widuri , Pemalang, ID-JT INDONESIA
16 J - - 01 Crab
Date Published: 04/01/2013
Desc:Canned Crab Meat
Problems:
CHLORAMPHENICOL;
PT. Tonga Tiur Putra
Date Published : 10/01/2009
Jl. Raya Sumur Tawang No.10, Kec. Kragan , Rembang, Jawa Tengah INDONESIA
16 J - - 01 Crab
Date Published: 10/01/2009
Desc:Crabmeat
Notes:DWPE date - 8/10/2009
Notes:DWPE date - 8/10/2009
PT. Tonga Tiur Putra
Date Published : 03/12/2012
Jl. R.e Martha Dinata, Km 7.8, Ds Suka , Jaya Lempasing, Kec. Padang Cermin. , Bandar Lampung, ID-LA INDONESIA
16 J - - 01 Crab
Date Published: 03/12/2012
Desc:Crabmeat
PT. Tonga Tiur Putra
Date Published : 12/21/2011
Jl. Raya Boulevard Barat , Komplek Plaza Pasifik A3/49 , Jakarta Utara, INDONESIA
16 J - - 01 Crab
Date Published: 12/21/2011
Desc:Crab Meat
PT. Tonga Tiur Putra
Date Published : 03/20/2012
Jl. Gajah Mada, Kel. Karang Anyar Pantai , Kec. Tarakan Barat , Tarakan, ID-KI INDONESIA
16 J - - 01 Crab
Date Published: 03/20/2012
Desc:Crab Meat
PT. Tonga Tiur Putra
Date Published : 03/07/2011
Pelabuhan Perikanan Kejawanan , Cirebon, ID-JB INDONESIA
16 J - - 01 Crab
Date Published: 03/07/2011
Desc:Crabmeat
PT. Windika Utama
Date Published : 08/14/2010
Jalan Beringin Raya No. 37 , Kel. Wonosari, Kec. Ngaliyan , Semarang, Central Java INDONESIA
16 J - - 01 Crab
Date Published: 08/14/2010
Desc:Crabmeat
PTTRANS SEAFOOD INDUSTRY
Date Published : 12/28/2011
JALAN PULAU SUMBAWA II NO 8 B , KIM II , Medan, Sumatera Utara INDONESIA
16 J - - 01 Crab
Date Published: 12/28/2011
Desc:Crabmeat
Pt. Mina Global Mandiri
Date Published : 06/15/2010
Jl. Raya Cikampek - Purwakarta Km 5 , Purwakarta, Id-jb INDONESIA
16 J - - 01 Crab
Date Published: 06/15/2010
Desc:Crabmeat
Problems:
CHLORAMPHENICOL;
VENEZUELA
PROCESADORA "EL CANGREJITO DEL MAR" C.A. (PROCAMAR, C.A.)
Date Published : 08/08/2011
AVENIDA PRINCIPAL DE LA GUAJIRA , LA CANADA DE URDANETA, VE-V VENEZUELA
16 J - - 01 Crab
Date Published: 08/08/2011
Desc:Crabmeat
VIETNAM
Agifish Company
Date Published : 09/16/2009
2222 Tran Hung Dao Street , Long Xuyen City, An Giang Province VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 8/30/2005
Ba Tri Seafood Factory,
Date Published : 09/16/2009
Hamlet 8, An Thuy Ward,ba Tri District, , Ben Tre Province, VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 8/10/2004
Hai Nam Co., Ltd.
Date Published : 09/16/2009
27 Nguyen Thong Street , Phu Hai Ward , Phan Thiet City, Binh Thuan VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 3/29/2004
Hai Nam Co., Ltd.
Date Published : 09/16/2009
55 Pham Ngoc Thach St , District 3 , Ho Chi Minh City, Vn-65 VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 10/18/2006
INVESTMENT COMMERCE FISHERIES CORPORATION (INCOMFISH)
Date Published : 01/22/2010
A77/i Road No.7, Vinh Loc Ip. , Binh Chanh District , Hochiminh, VN-65 VIETNAM
16 J - - 01 Crab
Date Published: 01/22/2010
Notes:DWPE date - 9/18/2008
Ky Lan Seafood Processing Joint Stock Company
Date Published : 09/16/2009
Lot A 12. Section A, South of Phan Thiet , Lac Dao Ward, Vietnam , Phan Thiet City, Binh Thuan VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 6/18/2009
Minh Hai Nissui Girimex Company
Date Published : 09/16/2009
(Minh Hai Nigico), National Road 1a Ho , Minh Hai Province, VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 4/19/2005
NGOC Ha Co., Ltd.
Date Published : 01/25/2013
5/159 Truong Son Street , Thu Duc District , Ho Chi Minh City, VN-65 VIETNAM
16 J - - 01 Crab
Date Published: 01/25/2013
Desc:Crabmeat
Ngoc Ha Co Ltd
Date Published : 01/25/2013
Hoi Hamlet, Kim Son Village, Chau Thanh , Tien Giang Provence , Ho Chi Minh City, VIETNAM
16 J - - 01 Crab
Date Published: 01/25/2013
Desc:Crabmeat
Phu Yen Seafood Corp.
Date Published : 09/16/2009
213 Hoa Binh Street, 2nd Floor, , Tan Bihn District , Ho Chi Minh City, VN-NOTA VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 2/25/2004
Saigon Aquatic products trading joint - stock company
Date Published : 09/16/2009
Lot 4-6-8 1a Street Tan Tao Industrial , binh tan district, HoChiMinh City, VN-65 VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 5/29/2009
Seagift Company Limited
Date Published : 09/16/2009
7/9 Binh Duc 2, Binh Hoa Ward , Thuan An Town, VN-57 VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 1/24/2008
Tho Quang Seafood Processing and Export Company
Date Published : 09/16/2009
Danang Fisheries Service Industrial Zone , Son Tra District , Da Nang City, Vn-60 VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 6/24/2005
Unimex Hanoi Hochiminh City Branch
Date Published : 09/16/2009
53 Phan Dinh Phung St., Phu Nhuan Dist. , Hochiminh City, VIETNAM
16 J - - 01 Crab
Date Published: 09/16/2009
Notes:DWPE date - 3/24/2005
VIET NHAT MANUFACTURING TRADING IMPORT EXPORT CO.,LTD.
Date Published : 01/22/2010
C 34/1 2G ST., VINH LOC INDUSTRIAL PARK , Binh Chanh, Ho Chi Minh, thanh pho VIETNAM
16 J - - 01 Crab
Date Published: 01/22/2010
Notes:DWPE date - 9/18/2008
VIET NHAT SEAFOOD CORPORATION
Date Published : 01/22/2010
C34/1, 2g Str., Vinh Loc Industrial Park , Binh Chanh Dist., , Ho Chi Minh, VN-65 VIETNAM
16 J - - 01 Crab
Date Published: 01/22/2010
Notes:DWPE date - 9/18/2008
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