"Detention Without Physical Examination of Frozen and Refrigerated Guacamole and Processed Avocado Products"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 3/12/2024 updates the reason for alert, guidance section including the agency contacts, and charge code section. Changes to the import alert are bracketed by asterisks (***). On June 1, 1993, DAL-DO, ***reorganized under the Division of Southwest Imports,*** received a fourteen lot entry of frozen guacamole. One of the lots from this entry was sampled by FDA and found positive for ***Listeria monocytogenes.*** The importer of record, b(4) , requested private laboratory analysis of the remaining thirteen lots. Private lab testing classified twelve of the remaining lots as non-violative and one (1) violative for L. monocytogenes. An audit was performed by DAL-DO of three of the lots classified as "non-violative" by the private laboratory. The FDA audit indicated two of the three lots sampled contained L. monocytogenes. The entire shipment was refused entry. On September 16, 1993, a second entry of frozen guacamole was made by Hermes Comercio Exterior. It too was sampled, detained, and refused by DAL-DO due to L. monocytogenes. On July 8, 1994, Dallas district sampled an entry of frozen avocado pulp consisting of two production codes. L. monocytogenes was detected in one code. In November 1997, Dallas district sampled a guacamole product labeled as "keep refrigerated" and manufactured by Industrias Citricolas De Montemorelos, Montemorelos N.L., Mexico. Analyses by Denver district laboratory disclosed the presence of ***L. monocytogenes*** in the product. In December 1997, DAL-DO detained an entry of frozen avocado halves due to the presence of ***L. monocytogenes.*** In February 1998, LOS-DO, ***reorganized under the Division of West Coast Imports,*** detained two entries of refrigerated avocado pulp due to the presence of ***L. monocytogenes.***

Product Description

Guacamole and Avocado Products; refrigerated or frozen

Charge

The article is subject to refusal of admission pursuant to 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health. ***[Adulteration; Section 402(a)(1)]*** OASIS charge code: LISTERIA

Guidance

***Divisions may detain, without physical examination, shipments of the products identified from firms on the Red List of this Alert. Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). DIO will coordinate with FDA's Center for Food Safety and Applied Nutrition (CFSAN) for concurrence. Release of Articles Subject to Detention without Physical Examination Under this Import Alert: In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not contain L. monocytogenes. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected 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 *** 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 Laboratory Procedure-Private Laboratory Analytical Packages. 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. 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 the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), 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 forwarded to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or 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 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 ***

Affected Countries (1)