Import Alert 20-07

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

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; review of import entry records; or through review of an importer's juice reconditioning proposal.

Districts may detain, without physical sampling and analysis, juice from foreign processors as noted in 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.

Foreign processors listed on the Red List of this import alert who would like to request removal from that list 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 its corrective actions, accompanied by documentation. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

The above information should be submitted to CFSAN's Office of Compliance, Division of Enforcement, at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance/Division of Enforcement
Food Adulteration Assessment Branch (HFS-607)
5100 Paint Branch Parkway
College Park, MD 20740

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.


RED LIST OF IMPORT ALERT 20-07
DETENTION WITHOUT PHYSICAL EXAMINATION FOR SPECIFIED COMBINATIONS OF FOREIGN
PROCESSORS AND JUICE PRODUCTS


Currently no firms are subject to DWPE under this Import Alert

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 whereby it may have been rendered injurious to health, due to failure of the foreign processor to comply with 21 CFR Part 120 [Adulteration, 402(a)(4)]."

OASIS CHARGE CODE: JUICEHACCP

PROBLEM: Failure of foreign processor(s) to comply with requirements of 21 CFR Part 120, "Hazard Analysis and Critical Control Point (HACCP) Systems"