IA #16-127 - 2/24/04,"IMPORT ALERT # 16-127, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF CRABMEAT DUE TO CHLORAMPHENICOL"
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 11/15/04
CHINA (CN)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
Crabmeat Jie Yang Rex Foods Co., Ltd. 8/9/04
16J- -01 Jiedong Economic Development District
Hengshan Village
Jiedong, Guangdong
China
FEI# 3004259815
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
INDIA (IN)
PRODUCT/ MANUFACTURER DWPE
PRODUCT CODE DATE
Crabmeat Handy-Waterbase India Pvt.Ltd. 3/8/04
16J- - 01 Plot No.C-3, Sipcot Industrial Complex
Madathur Post
Tuticorin, India
FEI# 3004323875
INDONESIA (ID)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
Crabmeat CV Malindo Perksa 1/30/04
16J- - 01 Sejati
Jalan Darmo Baru Barat
I No. 32 Surabaya
Jawa Timur, Indonesia
FEI# 3004006748
Crabmeat Pt. Kemilau Bintang Timur 8/9/04
16J- -01 Jl Kima 3, Kav 2A
Kaya Biringkanaya
Makassar, Sulawesi
Selatan, Indonesia
FEI# 3004258191
Crabmeat P.T. Medan Tropical Canning 3/12/04
16J- -01 and Frozen Industries
1-C Jalan Riau Medan
Ind. State Mabar
Jalan K.L. Yos Sudarso Km 10.5
Medan, Indonesia
FEI #8830
Crabmeat PT. Pasteuri Tower Sumatra 4/27/04
16J- -01 Jl. K.L. Yos Sudarso
Km. 10.5 Kawasan Industri Medan
Medan 20242
Indonesia
FEI# 3004404101
Crabmeat P.T. Toba Surimi 11/26/03
16J--01 Industries
Jalan Pulau Kangean
No.5 Kawasan Industri Medan
K.L. Yos Sudarso Km 10.5
Medan, Indonesia
FEI #3003461748
VIETNAM (VN)
PRODUCT/ MANUFACTURER/ DWPE
PRODUCT CODE PROCESSOR DATE
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 Hainam Co., Ltd. 3/29/04
16J- -01 Thong Nhat Street
Phu Hai, Phan Thiet
Binh Thuan Province
Vietnam
FEI# 3002673573
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 Thang Loi Frozen Foods Enterprise 3/11/04
16J- -01 157 Hung Phu St., Dist. 8
Ho Chi Minh City
Vietnam
FEI# 1000594420