Import Alert 20-07

Import Alert # 20-07

Published Date: 12/23/2025

Type: DWPE

Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation

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.***

***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 Human Foods Program (HFP) has determined a foreign processor has failed to meet the requirements under 21 CFR Part 120. The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by HFP on a case-by-case basis. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO).

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 sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from DWPE will be evaluated by DIO and referred to Human Foods Program Imports Enforcement Branch for review.

***
Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@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 the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

                                                                                                                                                          ***

Juice

***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

Desc: Ready to eat (RTE); Shelf-stable; Still and Sparkling Grape Juice

Notes:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: All Juice Pulp Products

Desc: 100% Coconut Water

Desc: 100% Coconut Water

Desc: All acidified juice/fruit extracts; various flavors/container types

Notes: FDA conducted an inspection of this acidified juice manufacturing facility finding serious deviations of the Hazard Analysis and Critical Control Point (HACCP) Systems (21 CFR Part 120) regulation. Based on FDA’s inspectional findings and the firm’s inadequate response to findings, the firm’s acidified juice products appear to be adulterated withing the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Specific violations include: 120.8 – Failure to identify Clostridium botulinum growth and/or toxin formation as a reasonably likely hazard and 120.6(b) – Not monitoring the sanitation conditions and practices with sufficient frequency.           

Desc: All acidified juice/fruit extracts; various flavors/container types

Notes: FDA conducted an inspection of this acidified juice manufacturing facility finding serious deviations of the Hazard Analysis and Critical Control Point (HACCP) Systems (21 CFR Part 120) regulation. Based on FDA’s inspectional findings and the firm’s inadequate response to findings, the firm’s acidified juice products appear to be adulterated withing the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Specific violations include: 120.8 – Failure to identify Clostridium botulinum growth and/or toxin formation as a reasonably likely hazard and 120.6(b) – Not monitoring the sanitation conditions and practices with sufficient frequency.           

Desc: All acidified juice/fruit extracts; various flavors/container types

Notes: FDA conducted an inspection of this acidified juice manufacturing facility finding serious deviations of the Hazard Analysis and Critical Control Point (HACCP) Systems (21 CFR Part 120) regulation. Based on FDA’s inspectional findings and the firm’s inadequate response to findings, the firm’s acidified juice products appear to be adulterated withing the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Specific violations include: 120.8 – Failure to identify Clostridium botulinum growth and/or toxin formation as a reasonably likely hazard and 120.6(b) – Not monitoring the sanitation conditions and practices with sufficient frequency.           

Desc: All acidified juice/fruit extracts; various flavors/container types

Notes: FDA conducted an inspection of this acidified juice manufacturing facility finding serious deviations of the Hazard Analysis and Critical Control Point (HACCP) Systems (21 CFR Part 120) regulation. Based on FDA’s inspectional findings and the firm’s inadequate response to findings, the firm’s acidified juice products appear to be adulterated withing the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Specific violations include: 120.8 – Failure to identify Clostridium botulinum growth and/or toxin formation as a reasonably likely hazard and 120.6(b) – Not monitoring the sanitation conditions and practices with sufficient frequency.           

Desc: Cherimoya fruit juice pulp

Desc: Cherimoya fruit juice pulp

Desc: Cherimoya fruit juice pulp

Desc: Lucuma Fruit Juice pulp

Desc: Cherimoya fruit juice pulp

Desc: All coconut water products (retail and bulk)

Notes:                                                                     

Desc: All coconut water products (retail and bulk)

Notes:                                                                     

Desc: All coconut water products (retail and bulk)

Notes:                                                                     

Desc: All coconut water products (retail and bulk)

Notes:                                                                     

Desc: Coconut Water

Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to prevent c. bot.

Desc: Coconut Water

Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to prevent c. bot.

Desc: Coconut Water

Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to prevent c. bot.

Desc: Coconut Water

Notes: Firms Juice HACCP plan does not have a 5 log reduction in the process to prevent c. bot.

Desc: Frozen; Ready-To-Drink Coconut Juice Beverage

Desc: Frozen; Ready-To-Drink Coconut Juice Beverage

Desc: Frozen; Ready-To-Drink Coconut Juice Beverage

Desc: Frozen Coconut Water

Desc: Shelf stable Lemon Juice

Notes: HACCP plan for 100% lemon juice from concentrate, does not include control measures that will consistently produce a 5-log reduction of the most resistant microorganism, Listeria monocytogenes.