Import Alert 20-03

(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 # 20-03
Published Date: 05/17/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Dried Fruits Due To Lead"

Reason for Alert:

In January and February, 1996, BUF-DO sampled two lots of Turkish sultanas, a small, yellow, seedless raisin, based on information received from SEA-DO. Lead analysis revealed levels in excess of 1 ppm in both samples. Screening for lead in other shipments of Turkish raisins indicate lead levels ranging from 0.83 to 0.98.



Additionally, Canada's Health Protection Branch has performed extensive lead testing of Turkish raisins with results frequently indicating lead levels of concern to FDA.



FY'96 data for Turkish raisins indicate that 15 of 22 samples analyzed for lead were found to contain levels in excess of 0.250 ppm. This represents a violation rate of 68%. In December, 1996, detention without physical examination was extended to all Turkish sultanas.



During January, 1997, BUF-DO collected a sample of Mexican raisins that were transshipped through Canada. Analysis by NERL indicated lead levels of 317 ppb and 270 ppb of original and check analysis respectively.



***During 2006, repeated findings of lead levels considered unsafe were found in samples of imported dried fruit collected for analysis under CPGM 7304.019, "Toxic Elements in Food and Foodware, and Radionuclides in Food."



Sweetened prunes from Taiwan and salted plums from Mexico were found to

contain lead levels of 1.1 mg/kg and 1.4 mg/kg respectively.***

Guidance:

Districts may detain without physical examination entries of ***dried fruit***from the individual firms listed on the attachment for this alert.



Districts should submit a recommendation for detention without physical examination for any ***dried fruit*** shipment found to contain lead in excess of ***0.1*** ppm. ***DIOP and CFSAN will evaluate regulatory packages on a case by case basis. Evidence for firms requesting removal from DWPE should be forwarded to DIOP. DIOP will forward the supporting scientific evidence to CFSAN for evaluation.***



***For questions concerning compliance or criteria for the release of shipments, contact CFSAN/DE/Product Adulteration Branch.***



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.



All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

***DRIED FRUIT***

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health." [Adulteration, Section 402(a)(1)]



OASIS charge code - PB-FOODS

Countries

TURKEY

  • (20 A - H 10) Raisins (Dried Grapes) (Berry), Ntrl/Artfcl Dried
    Problems:LEAD;
  • (20 B - - 10) Raisins, Dried or Paste
    Problems:LEAD;

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


CANADA


Amazin' Raisin International
Date Published : 09/18/2009
77 Comeau St , PO Box 430 , Atholville, NB CANADA
20 A - - 10 Raisins (Dried Grapes) (Berry)
Date Published: 09/18/2009

Desc: All Raisins including flavored raisins

20 B - - 10 Raisins, Dried or Paste
Date Published: 09/18/2009

Desc: All Raisins including flavored raisins


CHINA


CangZhou Fuda Imp. & Exp. Co., Ltd.
Date Published : 04/22/2013
3-3602,shuxi Street,yunhe District , CangZhou,, CN-13 CHINA
21 H - - 05 Dates, Dried or Paste
Date Published: 04/22/2013

Desc: Dried Dates

Guangdong Camey Food Co.,
Date Published : 04/07/2017
Xilong Village , Tiepu Town , Chaozhou, Guangdong CHINA
21 G - - 15 Prunes (Dried Plums) (Pit Fruit)
Date Published: 04/07/2017

Desc: Dried Salty Plum

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 04/07/2017

Desc: Dried Salty Plum

Leading Star Trading Co
Date Published : 09/18/2009
Fenjiang Rd , Guangdong, CHINA
20 A - - 10 Raisins (Dried Grapes) (Berry)
Date Published: 09/18/2009

Notes: Raisins

20 B - - 10 Raisins, Dried or Paste
Date Published: 09/18/2009

Notes: Raisins

Shun Tai Food Co., Ltd.
Date Published : 09/18/2009
Industry Antou, Guantang , Chaoan, Guangdong CHINA
20 A - - 10 Raisins (Dried Grapes) (Berry)
Date Published: 09/18/2009

20 B - - 10 Raisins, Dried or Paste
Date Published: 09/18/2009

Zhongshan Mcpl Zhengfeng Dried Fruit Foodstuffs I/e Co., Ltd
Date Published : 06/22/2010
Xieyu Rd, Keji Ave , Torch High-tech Ind. Development Zone , Zhongshan, Guangdong CHINA
21 H - - 14 Plum, Dried or Paste
Date Published: 06/22/2010

Desc: Plum

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 06/22/2010

Desc: Plums

Zi Jing Yuk Hin Enterprise Co., Ltd
Date Published : 05/17/2018
Long Wo Town , Zi Jing County , Heyuan City, Guangdong CHINA
21 H - - 14 Plum, Dried or Paste
Date Published: 05/17/2018

Desc: Dried Plums

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 05/17/2018

Desc: Dried Plums

yuk hin enterprise foodstuff
Date Published : 05/17/2018
517428 Piano Village , Long Wo Town , Heyuan City, Guangdong CHINA
21 H - - 14 Plum, Dried or Paste
Date Published: 05/17/2018

Desc: Dried Plums

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 05/17/2018

Desc: Dried Plums


HONG KONG


Sanwa Food Enterprises Company
Date Published : 05/16/2011
Flat B, 9/F SUNTISE INDUSTRIAL BUILDING , 10 HONG MAN STREET CHAI WAN , Hong Kong, HK-NA HONG KONG
21 H - - 14 Plum, Dried or Paste
Date Published: 05/19/2011

Desc: Plums

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 05/19/2011

Desc: Plums

21 S - - 99 Subtropical and Tropical Fruit, N.E.C.
Date Published: 05/16/2011

Desc: Plums


IRAN


Nazarico
Date Published : 04/13/2018
Zangi Abad Rd 2KM , Kerman, Kerman IRAN
20 B - - 99 Berries, Dried or Paste, N.E.C.
Date Published: 04/13/2018

Desc: Dried Barberries


MALAYSIA


KEE WEE HUP KEE FOOD MANUFACTURE (M) SDN BHD
Date Published : 09/03/2014
Cemerlang 81800 Ulu Tiram, Johor , 14 Jalan Mahir 5 , Ulu Tiram, Johor MALAYSIA
21 H - - 14 Plum, Dried or Paste
Date Published: 09/03/2014

Desc: EGO seedless plum
Notes: Tris Enterprise states they are a “sister” firm for Kee Wee. Tris Enterprise acts as the exporting arm for Kee Wee. Kee Wee does not export itself- it uses Tris Enterprise. Kee Wee is listed on product label under “Manufactured for” and is listed on the invoice as the supplier. Both firms to be included on the IA in order to ensure coverage of the product.
Problems: LEAD;

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 09/03/2014

Desc: EGO seedless plum
Notes: Tris Enterprise states they are a “sister” firm for Kee Wee. Tris Enterprise acts as the exporting arm for Kee Wee. Kee Wee does not export itself- it uses Tris Enterprise. Kee Wee is listed on product label under “Manufactured for” and is listed on the invoice as the supplier. Both firms to be included on the IA in order to ensure coverage of the product.
Problems: LEAD;


MEXICO


Alicia Alvarez Gutierres
Date Published : 02/11/2015
Chicalote 2620 , Mercado de Abastos , Guadalajara, Jal MEXICO
21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 02/11/2015

Desc: Dried Prunes
Problems: LEAD;

Grupo Agroindustrial Sonorense S.A.
Date Published : 09/18/2009
Carretera A Nogales Km 5 , Hermosillo, Sonora MEXICO
20 A - - 10 Raisins (Dried Grapes) (Berry)
Date Published: 09/18/2009

20 B - - 10 Raisins, Dried or Paste
Date Published: 09/18/2009

ISMAEL MACIAS ARELLANO
Date Published : 02/03/2015
Calle Queretaro Norte NO. 45 , Col. CENTRO , Acaponeta, Nayarit MEXICO
21 H - - 14 Plum, Dried or Paste
Date Published: 02/03/2015

Desc: Dehydrated Red Plums
Problems: LEAD;

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 02/03/2015

Desc: Dehydrated Red Plums
Problems: LEAD;

Productos Hola del Noroeste, S.A de C.V
Date Published : 09/18/2009
Avenida Lerdo No. 691 , Primera Seccion Zona Centro , Mexicali, BC MEXICO
21 H - - 14 Plum, Dried or Paste
Date Published: 09/16/2010

Desc: Dried Plum with Chile

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 09/16/2010

Desc: Dried Plum with Chile

Twang Mexico SA de CV
Date Published : 09/18/2009
Centenario 6-a , El Rufugio , Cuidad Fernandez, MX-SLP MEXICO
20 A - - 10 Raisins (Dried Grapes) (Berry)
Date Published: 09/18/2009

20 B - - 10 Raisins, Dried or Paste
Date Published: 09/18/2009

21 G - - 14 Plum (Pit Fruit)
Date Published: 09/18/2009

Desc: Salted

21 H - - 14 Plum, Dried or Paste
Date Published: 09/18/2009

Desc: Salted

28 Y - - -- Spices, Flav & Salt N.E.C.
Date Published: 09/18/2009

Notes: This product is coded as a spice in OASIS


SINGAPORE


Kee Wee Hup Kee Food Manufacture Pte. Ltd.
Date Published : 06/06/2017
24 Tuas Avenue 7 , Singapore, SINGAPORE
21 H - - 14 Plum, Dried or Paste
Date Published: 06/06/2017

Desc: Seedless Plums (Liquorice Flavor)

21 J - - 14 Plum, Jam, Jelly, Preserves, Marmalade, Butter or Candied
Date Published: 06/06/2017

Desc: Seedless Plums (Liquorice Flavor)

Tris Enterprises
Date Published : 09/03/2014
No.24 , Tuas Avenue 7 , Sinagore, HK-NA SINGAPORE
21 H - - 14 Plum, Dried or Paste
Date Published: 09/03/2014

Desc: EGO seedless plum
Notes: Tris Enterprise states they are a “sister” firm for Kee Wee. Tris Enterprise acts as the exporting arm for Kee Wee. Kee Wee does not export itself- it uses Tris Enterprise. Kee Wee is listed on product label under “Manufactured for” and is listed on the invoice as the supplier. Both firms to be included on the IA in order to ensure coverage of the product.
Problems: LEAD;

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 09/03/2014

Desc: EGO seedless plum
Notes: Tris Enterprise states they are a “sister” firm for Kee Wee. Tris Enterprise acts as the exporting arm for Kee Wee. Kee Wee does not export itself- it uses Tris Enterprise. Kee Wee is listed on product label under “Manufactured for” and is listed on the invoice as the supplier. Both firms to be included on the IA in order to ensure coverage of the product.
Problems: LEAD;


TAIWAN


SHUN TAI FOOD CO., LTD.
Date Published : 09/18/2009
No. 2, Lane 141, Sec. 1, Chung Shang , Road, Mei Kang Tsun, Ta Tsun , CHANG HWA, TW-CHA TAIWAN
20 A - - 10 Raisins (Dried Grapes) (Berry)
Date Published: 09/18/2009

20 B - - 10 Raisins, Dried or Paste
Date Published: 09/18/2009

21 G - - 14 Plum (Pit Fruit)
Date Published: 09/18/2009

Desc: Dried cured plums

21 G - - 15 Prunes (Dried Plums) (Pit Fruit)
Date Published: 09/18/2009

Desc: Dried cured plums

21 H - - 14 Plum, Dried or Paste
Date Published: 09/18/2009

Desc: Dried cured plums

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 09/18/2009

Desc: Dried cured plums

Sanh Yuan Enterprise Co., Ltd.
Date Published : 08/20/2010
108-1, Sec.1, Hsin Sheng S. Road , Taipei, TW-TPE TAIWAN
21 G - - 14 Plum (Pit Fruit)
Date Published: 08/20/2010

Desc: Dried Plums/Prunes

21 G - - 15 Prunes (Dried Plums) (Pit Fruit)
Date Published: 08/20/2010

Desc: Dried Plums/Prunes

21 H - - 14 Plum, Dried or Paste
Date Published: 08/20/2010

Desc: Dried Plums/Prunes

21 H - - 15 Prunes (Dried Plums), Dried or Paste
Date Published: 08/20/2010

Desc: Dried Plums/Prunes

Yi Cherng Lii Co., Ltd
Date Published : 01/14/2010
NO. 7 Pusi Street , Chang Hua City, Tw-Cha TAIWAN
21 G - - -- Pit Fruit
Date Published: 01/14/2010

Desc: Dried Plums/Prunes
Problems: LEAD;

21 H - - -- Pit Fruit Dried/Paste
Date Published: 01/14/2010

Desc: Dried Plums/Prunes
Problems: LEAD;