"Detention Without Physical Examination of Raw Shrimp"

Reason for Alert

NOTE: The revision of this Import Alert (IA), dated 06/25/2025, updates the alert to include additional guidance on release of articles subject to detention without physical examination (DWPE) and removal from DWPE. Changes are bracketed by asterisks (***). During FY 1979, an extensive problem of Salmonella, decomposition, and filth in imported shrimp was identified. As a result, it became necessary to detain without physical examination imported raw shrimp from six countries (Bangladesh, Hong Kong, India, Indonesia, Taiwan, and Thailand). Note: Violations for Salmonella, decomposition or filth in raw shrimp and decomposition in cooked shrimp from India are covered under Import Alert #16-35, "Detention Without Physical Examination of Raw And Cooked Shrimp from India." If samples of shrimp from other countries or cooked shrimp from India are found violative for Salmonella, divisions should recommend firms for detention without physical examination under Import Alert #16-81, "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella."

Product Description

Fresh/Frozen Raw Shrimp

Charge

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food. [Adulteration, Section 402(a)(3)] OASIS charge code - FILTHY The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous or deleterious substance, which may render it injurious to health. [Adulteration, Section 402(a)(1)] OASIS charge code � SALMONELLA

Guidance

***Divisions may detain fresh (raw) and fresh frozen (raw) shrimp from Bangladesh, Hong Kong, Indonesia, Taiwan, and Thailand, without physical examination, for filth, decomposition, and Salmonella, except from those firms listed on the Green List of this Alert. Final recommendations for removal from the Green List 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 DWPE under this import alert, the owner, consignee and/or another responsible party ***for the affected goods should provide evidence that demonstrates that the product does not contain Salmonella, decomposition or filth. Such evidence may include private laboratory analysis of samples.*** Proper sampling and analytical records should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. ***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 (Addition to GREEN LIST): In order to remove firm's product from DWPE, information should be provided to the Agency to adequately demonstrate that the manufacturer 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). ***FDA recommends a firm requesting removal from DWPE provide the following information: 1. Results of the firm's investigation(s) into the problem (root cause analysis) (i.e. failure to prevent contamination with Salmonella, decomposition and filth) 2. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum: a. A description of current manufacturing processes; and b. Labeling, quality control analytical results, supporting records, etc. 3. Details and supporting documentation on the controls implemented to prevent future adulteration based on the root cause analysis. 4. Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses. 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 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 (5)