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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.

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.

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


List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)



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

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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