Import Alert 20-07
(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 # 20-07
Published Date: 10/04/2023
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 03/10/2022 updates the reason for alert, guidance section, agency contacts and the charge code language. Changes to the import alert are bracketed by asterisks (***).
Under regulation 21 CFR Part 120, any juice, whether foreign or domestic in origin, is required to be processed in accordance with the requirements of 21 CFR Part 120.
***In determining a foreign processor's compliance, FDA will use relevant information, which might include information from an inspection of the foreign processor; inspection of an importer; or review of import entry records.***
Under regulation 21 CFR Part 120, any juice, whether foreign or domestic in origin, is required to be processed in accordance with the requirements of 21 CFR Part 120.
***In determining a foreign processor's compliance, FDA will use relevant information, which might include information from an inspection of the foreign processor; inspection of an importer; or review of import entry records.***
Guidance:
***Divisions may detain without physical examination juice products from foreign processors identified on the Red List of this import alert.
DWPE will be indicated when CFSAN has determined a foreign processor has failed to meet the requirements under 21 CFR Part 120. All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Foreign processors identified on the Red List of this import alert that would like to request removal of detention without physical examination (DWPE) should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing corrective actions taken, accompanied by documentation. For guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive
ELEM 3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
Requests for removal from DWPE will be referred by DIO to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch for evaluation.
Questions or issues involving import operations should be addressed to the Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
***
DWPE will be indicated when CFSAN has determined a foreign processor has failed to meet the requirements under 21 CFR Part 120. All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Foreign processors identified on the Red List of this import alert that would like to request removal of detention without physical examination (DWPE) should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing corrective actions taken, accompanied by documentation. For guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive
ELEM 3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
Requests for removal from DWPE will be referred by DIO to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch for evaluation.
Questions or issues involving import operations should be addressed to the Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
***
Product Description:
Juice
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 120. [Adulteration, 402(a)(4)]***
OASIS charge code: JUICEHACCP
OASIS charge code: JUICEHACCP
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
COSTA RICA
TUBERCULOS DE COSTA RICA, S.A
Date Published : 03/30/2013
San Luis de Jimenez , Norte de la Escuela Anita Grande 2km
, Pococi,
Limon COSTA RICA
20 D - - -- Berry Juices or Concentrates
Date Published: 03/30/2013
Desc: All Juice Pulp Products
20 F - - -- Berry Purees
Date Published: 03/30/2013
Desc: All Juice Pulp Products
20 M - - -- Citrus Fruit Purees
Date Published: 03/30/2013
Desc: All Juice Pulp Products
20 S - - -- Core Fruit Juices or Concentrates
Date Published: 03/30/2013
Desc: All Juice Pulp Products
21 D - - -- Mixed Fruit Juices or Concentrates
Date Published: 03/30/2013
Desc: All Juice Pulp Products
21 F - - -- Mixed Fruit Purees
Date Published: 03/30/2013
Desc: All Juice Pulp Products
21 I - - -- Pit Fruit Purees
Date Published: 03/30/2013
Desc: All Juice Pulp Products
21 K - - -- Pit Fruit Juices or Concentrates
Date Published: 03/30/2013
Desc: All Juice Pulp Products
21 R - - -- Subtropical/Tropical Fruit Purees
Date Published: 03/30/2013
Desc: All Juice Pulp Products
21 X - - -- Subtropical/Tropical Fruit Pulp
Date Published: 03/30/2013
Desc: All Juice Pulp Products
JAMAICA
Naturefield Company Limited
Date Published : 01/04/2018
Galina St. Mary
, Kingston,
JM-02 JAMAICA
21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 01/04/2018
Desc: 100% Coconut Water
22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 01/04/2018
Desc: 100% Coconut Water
PERU
Agro Hidro
Date Published : 12/12/2012
Calle Banchero Rosi 193
, Lima,
PE-CAL PERU
21 R - - 26 Cherimoya (Subtropical and Tropical Fruit Purees)
Date Published: 12/12/2012
Desc: Cherimoya fruit juice pulp
21 S - - 26 Cherimoya (Subtropical and Tropical Fruits)
Date Published: 12/12/2012
Desc: Cherimoya fruit juice pulp
21 X - - 26 Cherimoya (Subtropical/Tropical Fruit Pulp)
Date Published: 12/12/2012
Desc: Cherimoya fruit juice pulp
21 X - - 99 Subtropical/Tropical Fruit Pulp, n.e.c.
Date Published: 12/12/2012
Desc: Cherimoya fruit juice pulp
21 X - - 99 Subtropical/Tropical Fruit Pulp, n.e.c.
Date Published: 12/12/2012
Desc: Lucuma Fruit Juice pulp
THAILAND
Cocos Enterprises (Thailand) Co. LTD
Date Published : 12/03/2014
6
, Mueang Samut Sakhon,
Samut Sakhon THAILAND
21 R - - 48 Coconut, Subtropical and Tropical Fruit Purees
Date Published: 06/11/2019
Desc: All coconut water products (retail and bulk)
Notes:
21 S - - 48 Coconut, Subtropical and Tropical Fruit
Date Published: 06/11/2019
Desc: All coconut water products (retail and bulk)
Notes:
21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 06/11/2019
Desc: All coconut water products (retail and bulk)
Notes:
21 X - - 48 Coconut, Subtropical and Tropical Fruit Pulp
Date Published: 06/11/2019
Desc: All coconut water products (retail and bulk)
Notes:
J.M. Food Industry
Date Published : 05/25/2016
Lat Sawai , 30; 74-76 Lamlookka Rd., Ladsawai, Lamlookka
, Lam Luk Ka,
Pathum Thani THAILAND
21 R - - 48 Coconut, Subtropical and Tropical Fruit Purees
Date Published: 05/25/2016
Desc: Coconut Water
Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to
prevent c. bot.
29 R - - 04 Bottled Water with Fruit Flavors, Noncarbonated (Nonmedicinal)
Date Published: 05/25/2016
Desc: Coconut Water
Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to prevent c. bot.
J.M. Food Industry Co., Ltd.
Date Published : 05/25/2016
2014/7 Paholyothin Soi 34, Paholyothin
, Bangkok,
THAILAND
21 R - - 48 Coconut, Subtropical and Tropical Fruit Purees
Date Published: 05/25/2016
Desc: Coconut Water
Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to
prevent c. bot.
29 R - - 04 Bottled Water with Fruit Flavors, Noncarbonated (Nonmedicinal)
Date Published: 05/25/2016
Desc: Coconut Water
Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to
prevent c. bot.
The Fruitory (Thailand) Co. Ltd
Date Published : 12/18/2015
41 , 9 Soi Tessaban 13 Bangyai
, Bang Yai,
Nonthaburi THAILAND
21 V - - 48 Coconut, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 12/18/2015
Desc: Frozen Coconut Water