IA #16-127 - 2/24/04,"IMPORT ALERT # 16-127, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF CRABMEAT DUE TO CHLORAMPHENICOL", ATTACHMENT 4/17/09
TYPE OF
ALERT: Detention Without Physical Examination (DWPE)
(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).
PRODUCT: Crabmeat
PRODUCT
CODE: See attachment
PROBLEM: Chloramphenicol
PAF: FAD (Food Additive)
PAC: 09006A
COUNTRY: See attachment
MANUFACTURER
FEI #: See attachment
IMPORTER'S
ID#: N/A
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)."
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: POIS CHLOR, CHLORAMP
RECOMMENDING
OFFICE: CFSAN, OC, DE, Imports Branch (HFS-606)
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 on the attachment to this
alert.
For questions or issues concerning science, science policy,
analysis, preparation, or analytical methodology, contact
the Division of Field Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
PREPARED BY: Doug Randes, DIOP, 301-443-6553
KEYWORDS: chloramphenicol, crabmeat
DATED LOADED
INTO FIARS: February 24, 2004
ATTACHMENT FOR IMPORT ALERT #16-127 4/17/09
BRAZIL (BR)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
Crabmeat Juncao Ind. E Com. De Pescados Ltda 10/18/06
16J- -01 Av. Jose Bonifacio, 214 Bairro Junc
Rio Grande
Brazil
FEI# 3004273312
CHINA (CN)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
Crabmeat Aquastar Food Shanghai Co., Ltd 01/24/08
16J[][]01 152 Bei Zhao Jia Zhai
Cailu, Pudong
Shanghai, China
FEI# 2000027197
Crabmeat The Freezing Plant of 1/27/03
16J--01 Guangdong Shantou
Aquatic Products Imp/Exp Co.
322 Anping Road
Shantou, China
FEI #3003184812
Crabmeat Longhai Gelin Seafoods Co., Ltd. 3/11/04
16J- -01 Gangwei Town, Longhai City
Fujian, China
FEI# 3004248242
Crabmeat Xiamen Liangfa Imp & Exp 3/11/03
16J--01 Trade Company
No. 87 Dongdu Road
Xiamen, China
FEI #3003259459
INDONESIA (ID)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
Crabmeat CV. Sira Guna Putra 6/27/08
16J[][]01 Jl. Pulau Solor (KIM II) Medan,
Sumatera Utara, Indonesia
FEI #3005432026
Crabmeat Pt. Kemilau Bintang Timur 8/9/04
16J- -01 Jl Kima 3, Kav 2A
Kaya Biringkanaya
Makassar, Sulawesi
Selatan, Indonesia
FEI# 3004258191
Crabmeat PT. Panji Saburai Putra 10/16/06
16J- -01 JL. Raya Tanjung Bintang NO. 99
Desa Serdang Kec. Tanjung Bintang
Lampung Selatan 35361
Indonesia
FEI# 3004268274
VIETNAM (VN)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
Crabmeat Agifish Company 8/30/05
16J- -01 1234 Tran Hung Dao St.
Longxuyen Town
Angiang Province
Vietnam
FEI# 3002371427
Crabmeat Ba Tri Seafood Factory 8/10/04
16J[][]01 Hamlet 8, An Thuy Ward
Ba Tri District
Ben Tre Province, Vietnam
FEI# 3004548500
Crabmeat Hai Nam Co., Ltd. 3/29/04
16J- -01 Nguyen Thong Street
Phu Hai Ward, Binh Thuan Province
Phan Thiet City, Vietnam
FEI# 3002673573
Crabmeat Hainam Co., Ltd. 10/18/06
16J- -01 55 Pham Ngoc Thach St
District 3
Ho Chi Minh City
Vietnam
FEI# 3004316997
Crabmeat Investment Commerce Fisheries 9/18/08
16J[][]01 Corporation (INCOMFISH)
Aka
Incomfish Corporation
A77/1 No. 7 Street
Vinh Loc Industrial Park
Binh Tan District
Ho Chi Minh City
Vietnam
FEI# 3004273615
Crabmeat Minh Hai Nissui Girimex Co. 4/19/05
16J- -01 (MINH HAI NIGICO)
1A National Highway
Ho Phong Town
Gia Rai District
Bac Lieu Province
Vietnam
FEI# 3002989477
Crabmeat Nam Hai Company Ltd. 8/28/06
16J--01 279 A Hung Vuong St.
An Lac Ward
Binh Chanh Dist.
Ho Chi Minh City
Vietnam
FEI #3004206311
Crabmeat Ngoc Ha Company 4/17/09
16J[][]01 Hoi H Hamlet Kin Son Village
Chau District
Ho Chi Ming City, Vietnam
FEI #3006404292
Crabmeat Phu Yen Seafood Corp. 2/25/04
16J- -01 213 Hoa Binh Street
2nd Floor
Tan Bihn District
Ho Chi Minh City
Vietnam
FEI# 3004266034
Crabmeat Seagift Company Ltd. 01/24/08
16J[][]01 7/9 Binh Duc
Binh Hoa, Thuan An
Binh Duong Province
Vietnam
FEI# 3004256588
Crabmeat SEASPIMEX VIETNAM 12/18/06
16J--01 Aka
Special Aquatic Products
Joint Stock Company
213 Hoa Binh Street
Hoa Thanh Ward
Tan Phu District
Ho Chi Minh City
Vietnam
FEI# 3004286078
Crabmeat Sotico Processing Seafood 9/12/07
16J[][]01 And Canning Factory, Song Thuan Ward,
Chau Thanh District, Binh Duc Ward,
Chau Thanh District, Tien Giang Province
Vietnam
FEI # 3004796934
Crabmeat Tho Quang Seafood Processing Chloramphenicol 6/24/05
16J[][]01 & Export Company
329052 LOS-DO Danang Fisheries Service
Industrial Zone
Tho Quang Ward Son Tra Dist.
Danang City, Vietnam
FEI# 3004261652
Crabmeat Unimex Hanoi Hochiminh City Branch 3/24/05
16J[][]01 53 Phan Dinh Phung St.
Phu Nhuan Dist.
Hochiminh City, Vietnam
FEI# 3004694044
Crabmeat Viet Nhat Seafood Corporation 9/18/08
16J[][]01 (VISEACORP)
Aka
Viet Nhat Manufacturing Trading
Import Export Co., Ltd.
C34/1, 2G Street
Vinh Loc Industrial Park
Binh Chanh District
Ho Chi Minh City
Vietnam
FEI# 3004271508
2000029414
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