IA #16-124 - 11/16/01, IMPORT ALERT #16-124, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF AQUACULTURE SEAFOOD PRODUCTS DUE TO UNAPPROVED DRUGS";
Attachment Revised 12/18/08
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: Aquaculture seafood
PRODUCT
CODE: See attachment
PROBLEM: Unapproved drug residues
PAF: ANT (Drug residues)
PAC: 04018
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 new animal drug (or conversion product
thereof) that is unsafe within the meaning of Section 512, which
is in violation of Section 402(a)(2)(C)(ii)."
OASIS CHARGE
CODE: VETDRUGRES
RECOMMENDING
OFFICE: CFSAN, OFP, DE, Imports Branch (HFS-606)
REASON FOR
ALERT: There has been an extensive commercialization and an increased
consumption rate of aquaculture seafood products. As this
industry grows, the use of unapproved new animal drugs and the
misuse of approved new animal drugs in seafood raised through
aquaculture also grows. The use of unapproved new animal drugs
will have an impact on the safety of aquaculture products for
consumers.
GUIDANCE: Districts may detain without physical examination 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
KEYWORDS: seafood, aquaculture, animal drugs
PREPARED
BY: Ted Poplawski, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: November 16, 2001 ATTACHMENT FOR IMPORT ALERT #16-124 12/18/08
CHINA (CN)
PRODUCT/ MANUFACTURER/ DRUG DWPE
PRODUCT CODE PROCESSOR RESIDUE DATE
Frog Legs Xiamen Tongan Yuanshui Ciprofloxacin 5/23/08
16M[][]01 Sea Products Co., Ltd. &
16X[][]42 No. 3 Xinxing Road Enrofloxacin
Xindian Town
Xiangan, Xiamen
China
FEI# 3001313967
Frozen Shrimp Ningbo Jiuzhou Food Co.,Ltd. Chloramphenicol 10/18/02
16J--05 No. 266 Songxi Rd.
16X--21 Xizhou Town
Xiangshan, China
FEI# 3002175364
Frozen Shrimp Shantou Dongtao Trade Co.,Ltd. Chloramphenicol 11/10/03
16J- -05 Rm. 1104 Building B
16X- -21 Guoxin Garded
Changping Road
Shantou, China
FEI# 3004080878
Frozen Shrimp Yelin Frozen Seafood Co. Chloramphenicol 6/23/03
16J -05 Southwest of Sport Park
16X- -21 Shanfen Road
Shantou, China
FEI# 3002953960
Frozen Shrimp Zhoushan Guotai Fisheries Chloramphenicol 10/7/02
16J 05 Co., Ltd.
16X 21 No. 148, Jiefang East Road
Zhoushan Puxi Development Zone
Zhejiang, China
FEI# 3002861292
Tilapia Haikou Quanyong Aquatic Frozen & Process Malachite Green
16A--58 Greenfood Town, Meilan District Newtown 4/19/07
16X--06 Haikou City, Hainan
China
FEI# 3004280036
Tilapia Jiachang Aquatic Product Malachite Green 8/18/06
Fillets Co., Ltd. Longhai
16A--58 Doumei, Gangwei Town
16X--06 Longhai, Zhangzhou City
Fujian Province
China
FEI# 3004248224
Tilapia Zhanjiang Universal Crystal violet 6/27/08
16A[][]58 Seafood Corp.
16X[][]06 27-28 Yongping Road
SN 452208 Zhanjiang, China
FEI# 3004285322
3004083827
MALAYSIA (MY)
PRODUCT/ MANUFACTURER/ DRUG DWPE
PRODUCT CODE PROCESSOR RESIDUE DATE
Shrimp Seiko Marine Products Sdn Bhd Chloramphenicol 3/17/08
16J[][]05 No. 30, Jalan Meru Indah 20
16X[][]21 Klang, Selangor
Malaysia
FEI #3004747480
Frozen Raw Soonfroze Corporation Chloramphenicol 12/28/05
Shrimp Sdn Bhd
16J[][]05 No. 542 Jalan Siakap
Perak Darul Ridzuan
Malaysia
FEI# 3004604944
Frozen Shrimp Straits Sea Foods Chloramphenicol 6/23/03
16J- -05 Trading Co., Sdn. Bhd.
16X- -21 P.O. Box 166
57 Industrial Estate
Sarikei, Sarawak
Malaysia
FEI# 1000283810
MEXICO (MX)
PRODUCT/ MANUFACTURER/ DRUG DWPE
PRODUCT CODE PROCESSOR RESIDUE DATE
Shrimp, raw Pesquera JR SA de CV Gentian Violet 3/30/2007
16J[][]05/ Emilio Barragan 1046
16X[][]21 Mazatlan, Mexico
332653 - SWID FEI# 3003107424
TAIWAN (TW)
FIRM NAME AND ADDRESS PRODUCT/CODE DRUG RESIDUE DWPE
DATE
Lucky Holder Frozen Food Frozen Grilled Malachite 6/9/06
Co., Ltd. Eel Green
No.6 Chien Pang Road 16A--15
Nei-Pu Industrial Zone 16X--99
Ping Tung Hsien
Taiwan
FEI# 3003463846
Song Cheng Enterprise Co.Ltd. Roasted Eel Malachite Green 9/14/06
469 Chung Cheng Road 16A--15
Feng Tien Vil 16X--99
Nei Pu Hsiang
Pingtung
Taiwan
FEI# 12934
Gallant Seafoods Corp. White Spotted Malachite Green 3/2/07
23 Fishing Harbor S. 1st Rd. Clarias
Kaohsiung 16A- -82
Taiwan 16X- -43
FEI# 3004259171
Yuw Chauan Industry Co., Ltd. Charcoal Broiled Malachite 5/4/06
No.50, Lung-Chao Road Eel Green
Wu Fang Village 16A-N15
Hsin Yuan 16A-T15
Hsiang Ping Tung 16X-N99
Taiwan 16X-T99
FEI #3002730841
THAILAND (TH)
PRODUCT/ MANUFACTURER DRUG RESIDUE DWPE
PRODUCT CODE DATE
Walking Clarias I.T. Foods Industries Ciprofloxacin 10/24/05
Fish Fillet, raw Co., Ltd. &
16A- -82 Samutsakorn Industrial Estate Enrofloxacin
16X- -43 39/108 Moo 2, Bangkrajao, Muang
Samutsakorn 74000
Thailand
FEI# 3004277883
VIETNAM (VN)
PRODUCT/ MANUFACTURER/ DRUG DWPE
PRODUCT CODE PROCESSOR RESIDUE DATE
Basa Fillets Agifish Company Ltd Ciprofloxacin 8/2/06
aka
Striped An Giang Fisheries Import Enrofloxacin
Pangasius & Export Joint Stock Co.
Fillets 1234 Tran Hung Dao St.
16A -82 Long Xuyen City
16X- 43 An Giang Province
Vietnam
FEI# 3002371427
Frozen Shrimp Phu Cuong Seafood Processing Chloramphenicol 08/8/05
16J[][]05 Import Export Co. Ltd
16X[][]21 454 Ly Thuong Kiet St.,Ward 6
Camau City, Vietnam
FEI# 3003336470
Frozen Shrimp Phu Tan Seafood Export Chloramphenicol 9/28/04
16J - - 05 Processing Factory
16X - - 21 (PHUTANEXCO)
Cai Doi Vam Town, Cai
Nuoc Dist., Camau Province
Vietnam
FEI# 3004249131
Frozen Shrimp The Son Company Ltd. Chloramphenicol 8/29/02
16J--05 1/3 Truong Son F4
16X--21 Tan Binh District
Hochiminh City
Vietnam
FEI #3003706339
Frozen Shrimp Tra Kha Seafood Processing Enrofloxacin 6/19/08
16J[][]05 Factory
16X[][]21 (Factory 69/Workshop III)
National Highway 1
Tra Kha Ward
Bac Lieu Town
Bac Lieu Province
Vietnam
FEI# 3003922366
Basa Catfish Afiex Seafood Industry Ciprofloxacin 6/16/05
Fillets 91 Nation Road Enrofloxacin
16X- -43 Chau Phu District
An Giang Province
Vietnam
FEI# 3004307841
Basa Fish, Anvifish Co., Ltd. Malachite 11/1/05
Frozen National Road 91 Green
16A--82 Than An Hamlet
16X--43 My Thoi Ward
Long Xuyen City
An Giang Province
Vietnam
FEI# 3005122170
Basa Fillet Agifish Company Ciprofloxacin 8/22/05
16A[][]82 1234 Tran Hung Dao St. Enrofloxacin
16X[][]43 Longxuyen Town
Angiang Province
Vietnam
FEI# 3002371427
Basa Catfish Vinh Long Aqua Processing Ciprofloxacin 6/16/05
Fillets Factory Enrofloxacin
16X- -43 No. 197, 14/9 Street
Vinh Long
Vinh Long Province
Vietnam
FEI# 3004311092
Tinfoil Barb Nha Trang Sea Morning Co., Malachite Green 10/17/08
Fish Ltd.
16A[][]99 4/8 Ngo Quyen Street
16X[][]99 Nhatrang City
Vietnam
FEI# 3004741947
Swai,(Striped Vinh Hoan Co., Ltd. Gentian Violet 12/18/08
Pangasaius National Road 30, Ward 11
16A[][]82 Cao Lahn Town
16X[][]43 Vietnam
FEI #2000046512
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