Note: The revision of this Import Alert (IA) dated 03/13/2023 updates the guidance section including agency contacts, and product description. Changes to the import alert are bracketed by asterisks (***). Produce is vulnerable to contamination with human pathogens during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Ready-to-eat produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove human pathogens.
***Ready-to-eat produce***
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)] OASIS charge code: POISONOUS
***Divisions may detain without physical examination, shipments of identified products from the firms on the Red List of this Import Alert for the pathogenic contamination indicated.*** If Divisions have questions about whether the contamination will be addressed through commercial processing or otherwise, the Divisions may contact CFSAN. Evidence that FDA may use to place a firm/produce item combination on the Red List of this Import Alert includes but are not limited to: * Two or more findings of Salmonella from the same entry or in more than one related entry; * Two or more findings of E. coli 0157:H7 from the same entry or in more than one related entry; * One or more findings of Shigella from the same entry or related entries. Divisions may contact CFSAN for questions about pathogen or parasite findings not listed above. Divisions should also be aware that a firm/produce item combination may be subject to this Import Alert and Import Alert #99-35, "Detention without Physical Examination of Fresh Produce that Appears to Have Been Prepared, Packed, or Held Under Insanitary Conditions." Divisions should contact CFSAN if they have questions about whether Import Alert #99-23, Import Alert #99-35, or both Import Alerts apply. Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). Release of Articles Subject to Detention Without Physical Examination under This Import Alert: ***In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain human pathogens. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.*** *** Beginning 12/02/2025 for analyte group Listeria, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm *** Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, 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 detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov. 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 involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues on policy, sample collection recommendations, or any other additional questions, not directly related to a detained entry, should be addressed to Human Foods Program Division of Enforcement at hfp-oce-officeofenforcement@fda.hhs.gov.
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 03/13/2023 updates the guidance section including agency contacts, and product description. Changes to the import alert are bracketed by asterisks (***). Produce is vulnerable to contamination with human pathogens during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Ready-to-eat produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove human pathogens.
Country-specific information is available in the full alert detail on the FDA website.
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