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Import Alert 16-02
(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 # 16-02
Published Date: 08/01/2011
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of All Dried Shark Fins and Dried Fish Maws Due to Filth
Reason for Alert:
Insect, rodent or other animal filth has long been a problem with dried shark fins of all types and dried fish maws. The FY-93 national detention data identified over 160 detentions from more than 20 countries.
This import alert replaces Import Alert #16-01 "Automatic Detention of Sharkfins (Sharkfin Cake) From Hong Kong", and Import Alert #16-02, "Automatic Detention of Dried Shark Fins And Dried Fish Maws From Talle, Ecuador " and combines and expands both alerts. The violation rate for both products is the same, and criteria for detention without physical examination have been met. Because no non-violative geographical area can be identified, both products are on detention without physical examination on a world-wide basis.
This import alert replaces Import Alert #16-01 "Automatic Detention of Sharkfins (Sharkfin Cake) From Hong Kong", and Import Alert #16-02, "Automatic Detention of Dried Shark Fins And Dried Fish Maws From Talle, Ecuador " and combines and expands both alerts. The violation rate for both products is the same, and criteria for detention without physical examination have been met. Because no non-violative geographical area can be identified, both products are on detention without physical examination on a world-wide basis.
Guidance:
Districts may detain, without physical examination, all dried shark fins, all dried fish maws, and dried shark cartilage powder derived from shark fins/maws without physical examination. A attachment to identify firms exempt from detention without physical examinatin will be issued as necessary.
Dried shark fins (all types, e.g., whole, shredded, cakes) dried fish maws, and shark cartilage powder shall be examined according to the procedures outlined in LIB 2957, Examination of Dried Fish for Microscopic Filth.
Dried shark fins (all types, e.g., whole, shredded, cakes) dried fish maws, and shark cartilage powder shall be examined according to the procedures outlined in LIB 2957, Examination of Dried Fish for Microscopic Filth.
Product Description:
Dried Shark Fins (All types, e.g., whole, shredded, cakes) Dried Fish Maws Dried Shark Cartilage Powder (utilizing dried shark fins/ maws as the source material)
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance, (insect, rodent, and/or other animal filth), or to be otherwise unfit for food [Adulteration, Section 402(a)(3)]."
OASIS charge code - FILTHY
OASIS charge code - FILTHY
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(16 Y - H 07) Fish Maw, Fishery Products, n.e.c.
(16 Y - H 08) Shark Fin, Fishery Products, n.e.c.
(54 G - - 04) Shark (Animal By-Products and Extracts)
ARGENTINA
Gaveteco S.A. Ind. Com.
Date Published : 09/10/2009
Av Belgrano 1281 , Buenos Aires, ARGENTINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes:Shark Cartilage Powder
Added - 3/12/1997
AUSTRALIA
Cottee Dairy Products Pty Ltd
Date Published : 09/10/2009
Level 2, 25 Merriwa St. , Gordon, NSW AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes:Ahark cartilage powder
Added - 5/2/1997
Name change - 4/78/1998
Cottee Health Products Pty Limited
Date Published : 09/10/2009
15b Rodborough Road, , French Forest,, AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes:Shark Cartilage Powder
Added - 11/19/1999
Lane Labs Pty Ltd
Date Published : 09/10/2009
36 Central Dr, Andrews , (formerly Box 840, Manly, Sydney 2095) , Brisbane, AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:Shark Cartilage Powder
Notes:Added - 6/1/1995 Address correction - 2/17/1998
Notes:Added - 6/1/1995 Address correction - 2/17/1998
Probiotec Pty
Date Published : 09/10/2009
68 Ogrady Drive , Paradise Point, AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage powder
Notes:Sodium chondroitin Date added - 10/18/2002
Notes:Sodium chondroitin Date added - 10/18/2002
CANADA
CV Technologies Inc.
Date Published : 12/30/2009
9411-20 Avenue , Edmonton, CA-AB CANADA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 12/30/2009
Desc:Shark cartilage
Notes:Added - 6/4/1996 Name/address change - 10/7/2002
Notes:Added - 6/4/1996 Name/address change - 10/7/2002
Natural Factors
Date Published : 09/10/2009
1550 United Blvd , Coquitlam, British Columbia CANADA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage
Notes:Sodium chondroitin Date added - 7/28/2003
Notes:Sodium chondroitin Date added - 7/28/2003
CHINA
Dingtao Sun Biochemical Factory
Date Published : 09/10/2009
You Ji, Fangshan Village,Dingtao County , Shandong Province, CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 12/30/2009
Desc:Chondroitin sulfate
Notes:Added - 12/30/2002
Notes:Added - 12/30/2002
Jiangyin TSI Pharmaceutical Company LTD.
Date Published : 09/10/2009
Sizhuang Garden District , West Area of Economic Development Zone , Jiangyin, CN-32 CHINA
16 Y - H 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes:Added - 2/5/2007
16 Y - H 08 Shark Fin, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes:Added - 2/5/2007
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:Shark cartilage powder
Notes:Added - 2/5/2007
Notes:Added - 2/5/2007
Shing Hop Trading Company
Date Published : 09/10/2009
G/F Des Vocux Rd West 12 Sai Yuen Lane , Hong Kong, CHINA
16 Y - H 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes:Fish maws
Date added - 11/8/2005
Shun Chang Warehousing Services
Date Published : 09/10/2009
47 Xin Xing Street , Zhang Mu Tou Town , Dongguan, Cn-44 CHINA
16 Y - H 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes:Fish maws
Date added - 7/20/2005
Sinotrans Guangdong Import&Export Trading Co.
Date Published : 09/10/2009
1125 Guang Yuan Road C , Guangzhou, CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage
Notes:Sodium chondroitin Date added - 2/2/1996
Notes:Sodium chondroitin Date added - 2/2/1996
Sirio Pharma Co., Ltd.
Date Published : 08/01/2011
( 11 Huangshanlu , Sh¿nt¿ush¿, CN-44 CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 08/01/2011
Desc:Shark Cartilage Soft Capsules
54 H - - 04 Fish Oil (Fats and Lipid Substances)
Date Published: 08/01/2011
Desc:Shark Cartilage Soft Capsules
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/01/2011
Desc:Shark Cartilage Soft Capsules
Yantai Tsi Nutritional Prod.Co.,Ltd
Date Published : 09/10/2009
Laiyang , Shandong, CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage concentrate
Notes:Sodium chondroitin Date added - 2/4/2004
Notes:Sodium chondroitin Date added - 2/4/2004
shing hop trading & seafood products mfg co.
Date Published : 09/10/2009
Ho Tang , Fung Jiang District , jiang men, CN-44 CHINA
16 Y - H 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes:Date added - 11/8/2005
COLOMBIA
Comexa
Date Published : 09/10/2009
Via A Mamonal No. 25-196 , Sector Albornoz. , Cartagena, CO-BOL COLOMBIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes:Shark Cartilage
Date added - 1/2/1996
COSTA RICA
Corporacion Procesdora de Cartilago S.A.
Date Published : 09/10/2009
Apartado Postal 86-5400 , Barranco, Puntarenas, COSTA RICA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes:Shark Cartilage
Added - 7/26/1995
HONG KONG
Hang Tai Marine Products Co.
Date Published : 09/10/2009
G/Fl., Shop No. G7 , 151 Connaught Road West , Hong Kong, HK-NA HONG KONG
16 Y - - 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes:Fish maws
Added - 2/23/2006
Kwan Kee Shark Fins Ltd
Date Published : 08/03/2010
58, Des Voeux Rd, 3/F , Hong Kong, HK-NA HONG KONG
16 Y - - 08 Shark Fin, Fishery Products, n.e.c.
Date Published: 08/03/2010
Desc:Dried Shark FIn
INDIA
Shark Line Exports
Date Published : 09/10/2009
Industrial Nagar, Changanacherry , Kerala, INDIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage/bones
Notes:Sodium chondroitin Date added - 10/9/1997
Notes:Sodium chondroitin Date added - 10/9/1997
INDONESIA
PT Eksindo Jaya Terang Mustika
Date Published : 09/10/2009
Jl.pisangan Lama I No 7 , Jakarta, INDONESIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage
Notes:Sodium chondroitin Date added - 3/6/1996
Notes:Sodium chondroitin Date added - 3/6/1996
JAPAN
Kenko Corporation
Date Published : 09/10/2009
2-11 Uchikanda 3-Chomechiyoda-Ku , Tokyo, JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:Shark Cartilage Powder
Notes:Sodium Chondroitin Sulfate Added - 5/13/1997
Notes:Sodium Chondroitin Sulfate Added - 5/13/1997
Maruha Corporation
Date Published : 09/10/2009
8-1, Kiyohara Kogyo Danchi , Utsunomiya, Tochigi Prefecture JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:Shark Cartilage Concentrate
Notes:Sodium chondroitin Date added - 10/23/1995
Notes:Sodium chondroitin Date added - 10/23/1995
Maruha Corporation (office)
Date Published : 09/10/2009
1-2 1-Chome Otemachi Chiyoda-Ku , Tokyo, JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:Shark Cartilage Concentrate
Notes:Sodium chondroitin Date added - 10/23/1995
Notes:Sodium chondroitin Date added - 10/23/1995
Seikagaku Corporation
Date Published : 09/10/2009
1-5, Nihonbashi-Honcho 2-Chome , Chuo-ku , Tokyo, JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:shark cartilage/bones
Notes:Sodium chondroitin Date added - 11/4/1997
Notes:Sodium chondroitin Date added - 11/4/1997
MEXICO
Corporacion Nacional De Ventas, S.A.
Date Published : 09/10/2009
Insurgentes Sur No. 605-505 , Ciudad De Mexico, DF MEXICO
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes:Shark Cartilage
Added - 2/2/1996
Jose Jorge Peralta Pena
Date Published : 09/10/2009
Ave. Rayon #343 , Ensenada, Baja California Norte MEXICO
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc:Shark Cartilage
Notes:Shark cartilage Added - 7/20/2000 Name change - 8/14/2003
Notes:Shark cartilage Added - 7/20/2000 Name change - 8/14/2003
NEW ZEALAND
Aroma NZ Limited
Date Published : 12/30/2009
90 Waltham Road , Box 2683 , Waltham, NEW ZEALAND
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 12/30/2009
Desc:Shark cartilage
Notes:Added - 8/29/1994
Notes:Added - 8/29/1994
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