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Import Alert 99-12

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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 # 99-12
Published Date: 06/14/2012
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Canned Foods Due To Contamination From Lead Soldered Cans"

Reason for Alert:
On June 27, 1995, FDA published a final rule in the Federal Register which prohibited the use of lead solder to manufacture cans for packaging foods. The effective date of this regulation for products initially introduced or delivered for introduction into interstate commerce was December 27, 1995.

Guidance:
Prior to December 27, 1995, districts were required to analyze the food product to determine whether or not the levels of lead in the food exceeded action levels before recommending a detention action. LABORATORY ANALYSIS OF THE FOOD IS NO LONGER REQUIRED.

Districts may now evaluate the solder of the can to determine if lead is present. The testing procedure is listed in FDA Laboratory Information Bulletin 4041, "Identification of Lead Solder on a Metal Can Seam."

If the result of the test is positive, the lot should be detained and a recommendation for detention without physical examination should be
forwarded to DIOP. A single positive can is sufficient for a district to detain a shipment and recommend detention without physical examination. If the lot is mixed, the importer may submit a reconditioning proposal to request release of the portion of the lot which does not contain lead soldered cans.

If the result of the test is inconclusive, districts may contact Office of Compliance CFSAN for further guidance.

Districts may detain, without physical sampling and analysis, shipments of canned products specified in the attachment to this alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

Product Description:
All foods in lead soldered cans

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain lead solder, an unsafe food additive within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C)]."

OASIS charge code - INSAFE ADD


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



CHILE

Pesquera San Jose S.A. (FCE 09249)
Date Published : 09/16/2009

Avda. Pedro Aquirre Cerda 719 , Coronel, CHILE
16 A E - 22 Mackerel, Spanish or King
Date Published: 09/16/2009

Desc:canned Mackerel; all brands
Notes:DWPE date 11-3-98
Problems: LEAD;
16 A E - -- Fish
Date Published: 09/16/2009

Desc:Canned Mackerel (All Brands)
Notes:11/30/1998


FIJI

Morris Hedstrom
Date Published : 09/16/2009

unknown , unknown, FIJI
16 A E E 22 Mackerel, Spanish or King
Date Published: 09/16/2009

Desc:canned Mackerel
Notes:Distributor/Possible shipper for manufacturer Vo-Ko Industries (FEI 3001724298) DWPE 6-8-98

Ram Karan Dealers Ltd
Date Published : 09/16/2009

103 Bureta Street , Tamavua , Suva, Fj-C FIJI
16 A E E 22 Mackerel, Spanish or King
Date Published: 09/16/2009

Desc:canned Mackerel
Notes:SHPR for Vo-Ko Industries (FEI 3001724298) DWPE 6-8-98
Problems: LEAD;

Vo-Ko Industries Limited
Date Published : 09/16/2009

Gpo Box 13212 , Suva, FIJI
16 A E E 22 Mackerel, Spanish or King
Date Published: 09/16/2009

Desc:canned Mackerel
Notes:DWPE date 6-8-98
Problems: LEAD;


INDIA

Pachranga Foods
Date Published : 09/16/2009

C - 3, , Industrial Area , Panipat, Haryana INDIA
24 E - E 51 Peas
Date Published: 09/16/2009

Desc:Tenti Dela - green peas in oil
Notes:DWPE date 5-6-98
Problems: LEAD;
24 E - E 99 Bean and Pea Sprouts, N.E.C. (Vegetable)
Date Published: 09/16/2009

Desc:Tenti Dela - green peas in oil
Notes:DWPE date 5-6-98
Problems: LEAD;
24 E - I 51 Peas
Date Published: 09/16/2009

Desc:Tenti Dela - green peas in oil
Notes:DWPE date 5-6-98
Problems: LEAD;
24 E - I 99 Bean and Pea Sprouts, N.E.C. (Vegetable)
Date Published: 09/16/2009

Desc:Tenti Dela - green peas in oil
Notes:DWPE date 5-6-98
Problems: LEAD;


ISRAEL

Canary Inc.
Date Published : 04/28/2010

Silwad , Ramallah, IL-NOTA ISRAEL
12 C - - 15 Cheese, Goat, N.E.C.
Date Published: 04/28/2010

Desc:Goat Cheese
21 G - - 11 Olives, Green, (Pit Fruit)
Date Published: 04/28/2010

Desc:Green Olives
26 C - - 04 Olive Oil, Refined, Single Ingredient
Date Published: 04/28/2010

Desc:Olive Oil


LATVIA

Rezekne Dairies And Canneries (Stock Company)
Date Published : 09/16/2009

Atbrivosanas Aleja 155/1 , Rezekne, LATVIA
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:FCE# 11386 DWPE date 11-22-99
Problems: LEAD;


MOROCCO

unimer
Date Published : 09/16/2009

km11-routedes zenats , casablanca, MA-CAS MOROCCO
16 A - E 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 09/16/2009

Desc:Sardines
Notes:DWPE is only appropriate when the product from this firm is shipped by another firm
Problems: LEAD;


RUSSIA

Astrahan Konservprom
Date Published : 09/16/2009

1 Slavinskaya Square , Astrahan, RUSSIA
24 H E - 01 Egg Plant, Dried or Paste
Date Published: 09/16/2009

Desc:Eggplant paste
Notes:Importer: B & B International Connection, 2829 W. 21st St, Brooklyn, NY 11224- 2301, (FEI 1000567857) DWPE date 10-4-04
Problems: LEAD;

Dalriba Fish Kombinat Oshrovnoy
Date Published : 09/16/2009

Unknown Street , Shikotan Island, RUSSIA
16 A E - -- Fish
Date Published: 09/16/2009

Desc:Saury in oil
Notes:Importer for Linda International Trading, 4266 Ocean Ave, Brooklyn, NY 11235- 3730, (FEI 3003917556) DWPE date 10-4-04
Problems: LEAD;

JSC "RUDNYAKCONSEVMOLOKO"
Date Published : 09/16/2009

MOLKOMBINAT VILLAGE , RUDNYA TOWN , SMOLENSK, RU-SMO RUSSIA
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:Condensed milk (various flavors with cocoa; coffee; or sugar)
Notes:Distributor/Importer: B & B International Connection, 2829 W. 21st St Brooklyn, NY 11224-2301 (FEI# 1000567857) DWPE date 10-4-04
Problems: LEAD;
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:Condensed Milk (various flavors with cocoa; coffee or sugar)
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:Condensed milk (various flavors with cocoa; coffee; or sugar)
Notes:Distributor/Importer: B & B International Connection, 2829 W. 21st St Brooklyn, NY 11224-2301 (FEI# 1000567857) DWPE date 10-4-04
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:Condensed Milk (various flavors with cocoa; coffee or sugar)
Notes:10/4/2004
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:Condensed Milk (various flavors with cocoa; coffee or sugar)
Notes:11/4/2004
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:Condensed milk (various flavors with cocoa; coffee; or sugar)
Notes:Distributor/Importer: B & B International Connection, 2829 W. 21st St Brooklyn, NY 11224-2301 (FEI# 1000567857) DWPE date 10-4-04
Problems: LEAD;

JSC RUDNYAKONSERV MOLOKO
Date Published : 09/16/2009

POS. MOLKOMBINATA 1 , RUDNYA, RU-SMO RUSSIA
09 C E - 05 Milk, Flavored (Chocolate, Etc.)
Date Published: 09/16/2009

Desc:Canned milk-based drinks including Carmel Spread; Caramel Spread with coffee; Caramel Spread with cocoa; and Condensed Half/Half
Notes:US Distributor/Importer: Krasniy Octyabr, Inc., 76 Sullivan St, Brooklyn, NY 11231-1605 (FEI 3004284473) DWPE date 1-30-06
Problems: LEAD;
09 C E - 07 Half And Half (Milk and Cream)
Date Published: 09/16/2009

Desc:Canned milk-based drinks including Carmel Spread; Caramel Spread with coffee; Caramel Spread with cocoa; and Condensed Half/Half
Notes:US Distributor/Importer: Krasniy Octyabr, Inc., 76 Sullivan St, Brooklyn, NY 11231-1605 (FEI 3004284473) DWPE date 1-30-06
Problems: LEAD;

Kamchatneft Product
Date Published : 09/16/2009

3a Krasintsev Str , Kamchatsky, RUSSIA
16 Y E - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 09/16/2009

Desc:salmon roe
Notes:DWPE date 10-4-04 Distributor/Importer: >>>Awers American West East Russian System 12832 NE 14th Pl. Bellevue, WA 98005 FEI# 3003109099<<<
Problems: LEAD;

Kerch Fish Cannery
Date Published : 09/16/2009

41 Kirov Street , Kerch, RUSSIA
16 A E - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 09/16/2009

Desc:Kilka sprats in tomato sauce
Notes:DWPE 10-4-04
Problems: LEAD;
16 A E - 99 Fish, N.E.C.
Date Published: 09/16/2009

Desc:Kilka sprats in tomato sauce
Notes:DWPE 10-4-04
Problems: LEAD;

Murmansk Tralovy Flot
Date Published : 09/16/2009

43 Shmidta Street , Murmansk, Ru-Mur RUSSIA
16 A E - -- Fish
Date Published: 09/16/2009

Desc:Multiple products (Saury in own juice; Atlantic herring; cod liver)
Notes:US Importer is ADRO Intemational lnc., 1142 E. 5th St., Brooklyn, NY (FEI 1000312868) DWPE date 10-4-04
Problems: LEAD;
16 Y E - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 09/16/2009

Desc:Cod liver
Notes:US Importer is ADRO Intemational lnc., 1142 E. 5th St., Brooklyn, NY (FEI 1000312868) DWPE date 10-4-04
Problems: LEAD;

OAO XK "Dalmoreproduct"
Date Published : 09/16/2009

53 Pologaya Street , Vladivostok, RU-NOTA RUSSIA
16 A E - -- Fish
Date Published: 09/16/2009

Desc:Multiple products (saury blanched in oil; crabmeat; salmon)
Notes:DWPE 10-4-04
Problems: LEAD;
16 J E - -- Crustaceans
Date Published: 09/16/2009

Desc:Multiple products (Saury blanched in oil; crabmeat; salmon)
Notes:DWPE date 10-4-04
Problems: LEAD;

Ooo Ecopacific
Date Published : 09/16/2009

3a Kracincev Street , Petropavlosk-Kamchatsky, RUSSIA
16 Y E - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 09/16/2009

Desc:canned fish roe
Notes:DWPE date 10-29-03
Problems: LEAD;

Rilolovetzky Kolhoz Imeni
Date Published : 09/16/2009

Krasnodar Region 2 , Primosko, RUSSIA
16 Y E - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 09/16/2009

Desc:cod liver
Notes:Importer: Futures International-Alexis, LLC, 11 Liberty Ln., Somerset, NJ 08873-2812 (FEI# 3002705166) DWPE date 10-4-04
Problems: LEAD;
24 T E - 08 Cabbage (Leaf & Stem Vegetable)
Date Published: 09/16/2009

Desc:cabbage
Notes:Importer: Futures International-Alexis, LLC, 11 Liberty Ln., Somerset, NJ 08873-2812 (FEI# 3002705166) DWPE date 10-4-04
Problems: LEAD;
24 T E - 18 Kale (Leaf & Stem Vegetable)
Date Published: 09/16/2009

Desc:sea Kale
Notes:Importer: Futures International-Alexis, LLC, 11 Liberty Ln., Somerset, NJ 08873-2812 (FEI# 3002705166) DWPE date 10-4-04
Problems: LEAD;

Zao Borodino (Borodinskoe Pole)
Date Published : 09/16/2009

143240 Moscow OBL. , Mozhaisk Rayon , Moscow, RUSSIA
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 3-21-2001
Problems: LEAD;


UKRAINE

CJSC "Kupyansk Milk Canning Combinat"
Date Published : 09/16/2009

26 Lomonosov Street , Kup¿yansk, Kharkivska UKRAINE
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;

GAMMA Ltg
Date Published : 09/16/2009

Lebedinskiy Str., 15 , Vinnitsa, UA-05 UKRAINE
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 11-2-05
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 11-2-05
Problems: LEAD;
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 11-2-05
Problems: LEAD;

Gamma Ltd
Date Published : 09/16/2009

23 Chekhova Street , Vinnitsa, UKRAINE
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 11-2-05
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 11-2-05
Problems: LEAD;
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:condensed milk; canned
Notes:DWPE date 11-2-05
Problems: LEAD;

Izmail Fish Factory
Date Published : 09/16/2009

Kapikraiana 4 St. , Izmail, UA-51 UKRAINE
16 A - - 21 Herring
Date Published: 09/16/2009

Desc:canned herring
Notes:DWPE date 3-20-06
Problems: LEAD;
16 A - - 32 Salmon (Humpback, Silver, King, Sockeye, Etc.)
Date Published: 09/16/2009

Desc:canned salmon fillet
Notes:DWPE date 3-20-06
Problems: LEAD;

UKRAGROINVEST
Date Published : 09/16/2009

4 A Academician Krymsky Street , Kiev, UA-30 UKRAINE
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor: Ukrexpo, 6 Bylika St., Zhitomir, Ukraine (FEI 3003906846) Distributor: JSC Kupyansk Milk Canning Combinat, Kharkov, Ukraine (FEI 3003709751) Distributor: Prodium Inc., 12260 Willow Grove Roadbuilding 2, County of Kent, United Kingdom (FEI 3003821326) US Importer: Gourmet Bakery Company, 1333 Haines St.Jacksonville, FL 32206- 6035 (FEI 3003821323) DWPE date 10-4-04
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor: Ukrexpo, 6 Bylika St., Zhitomir, Ukraine (FEI 3003906846) Distributor: JSC Kupyansk Milk Canning Combinat, Kharkov, Ukraine (FEI 3003709751) Distributor: Prodium Inc., 12260 Willow Grove Roadbuilding 2, County of Kent, United Kingdom (FEI 3003821326) US Importer: Gourmet Bakery Company, 1333 Haines St.Jacksonville, FL 32206- 6035 (FEI 3003821323) DWPE date 10-4-04
Problems: LEAD;
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor: Ukrexpo, 6 Bylika St., Zhitomir, Ukraine (FEI 3003906846) Distributor: JSC Kupyansk Milk Canning Combinat, Kharkov, Ukraine (FEI 3003709751) Distributor: Prodium Inc., 12260 Willow Grove Roadbuilding 2, County of Kent, United Kingdom (FEI 3003821326) US Importer: Gourmet Bakery Company, 1333 Haines St.Jacksonville, FL 32206- 6035 (FEI 3003821323) DWPE date 10-4-04
Problems: LEAD;

Ukrexpo Pvt
Date Published : 09/16/2009

6 Bylika Treet , Zhitomir, UKRAINE
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;


UNITED KINGDOM

Prodium Inc
Date Published : 09/16/2009

12260 Willow Grove Roadbuilding 2 , County Of Kent, UNITED KINGDOM
09 C E - 03 Milk, Concentrated, Evaporated and Condensed
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;
09 D E - 03 Milk, Concentrated, Evaporated, Condensed, Low Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;
09 E E - 03 Milk, Concentrated, Evaporated, Condensed, Non Fat
Date Published: 09/16/2009

Desc:sweetened condensed milk
Notes:Distributor for LACF manufacturer Ukragroinvest (FEI 3004331576)
Problems: LEAD;

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