Import Alert 16-138

Import Alert # 16-138

Published Date: 01/29/2026

Type: DWPE

Detention Without Physical Examination of Seafood Products That Appear to Have Been Prepared, Packed or Held Under Insanitary Conditions

Salmonella in seafood is directly attributable to human or animal fecal contamination. Salmonella is not endemic to seafood. The occurrence of Salmonella in seafood is associated with fecal contamination of the water environment and/or by contamination of the seafood after harvest or during processing and is associated with insanitary conditions.

Listeria monocytogenes is a pathogen that may be introduced into a food processing facility from raw materials, humans, and equipment. The occurrence of Listeria monocytogenes in ready to eat (RTE) seafood is associated with insanitary conditions.

In addition, the presence of other pathogens in seafood products may also be associated with insanitary conditions.

This import alert (IA) addresses seafood products where the FDA has evidence that the products appear to be adulterated, within the meaning of 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

This import alert may be used in conjunction with other import alerts addressing adulteration under 402(a)(1) of the FD&C Act, including but not limited to: 16-18, 16-35, 16-39, 16-81.

Divisions may detain without physical examination, shipments of identified products or an article or articles of seafood products offered for import from the firms identified on the Red List of this IA.

Examples of evidence the FDA may use to place a firm or product on the Red List may include:

1. Analytical evidence: Violative samples of specific seafood products or multiple seafood products from an individual manufacturer will be considered in determining the products to place on Import Alert.

NOTE: For analytical evidence related to Listeria monocytogenes, products must be RTE seafood product(s).

Analytical evidence may include:

a. two or more lots of a specific seafood product from the same manufacturer, found positive for microbial pathogen(s) to consider subjecting the specific seafood product from the individual manufacturer to DWPE;

b. two or more lots of different seafood products from the same manufacturer found positive for microbial pathogen(s) to consider subjecting ALL seafood products from the individual manufacturer to DWPE;

Analytical evidence used as the evidentiary basis for addition to the Red List must be sufficient to show that the appearance of insanitary conditions. Samples from the same entry may not support the appearance of insanitary conditions. Consideration of whether the product is RTE may also be relevant in determining whether to recommend the product for DWPE.
Additionally, the product and the firm may be added to the Red List of the appropriate IA for the 402(a)(1) adulteration charge for the specific pathogen including but not limited to: 16-18, 16-35, 16-39, 16-81.

2. Epidemiological, traceback, historical food and environmental testing, and/or genetic analysis. For example, this may include evidence implicating a seafood product as the likely cause of illness and/or traceback evidence demonstrating that the firm prepared, packed, or held the implicated seafood product.

3. Evidence of inadequate sanitation controls or inadequate implementation of sanitation controls that has led to conditions of environmental contamination that results in the appearance of adulteration under 402(a)(4) of the FD&C Act. Evidence of inadequate controls can be obtained through various ways including inspections of the foreign processor or importer.

The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by the Human Foods Program (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).

NOTE: In cases where it appears that a product has been prepared, packed, or held under insanitary conditions, the appearance of a violation may not be resolved by reconditioning. If a firm is considering pursuing reconditioning, please contact the FDA Division compliance office listed in the FDA Notice of Action.

Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

When a firm and product(s) are on the Red List of this IA for a 402(a)(4) charge and simultaneously on the Red List of another IA for a 402(a)(1) charge, the firm should first address DWPE removal from the (a)(4) charge IA. This means that a firm should provide evidence that the conditions that gave rise to the appearance of insanitary conditions have been resolved before submitting private laboratory analytical package(s) (PLAP) testimony to request the release of specific entries that are subject to DWPE on other import alerts due to the appearance of 402(a)(1) adulteration.

In order to remove a firm/product from DWPE, the firm should submit documentation to FDA demonstrating that the firm has resolved the conditions that gave rise to the appearance of adulteration so that the Agency will have confidence that future entries will be in compliance with the Act.

Examples of such documentation may include:

1. A root cause analysis that identifies the likely source of the adulteration and route(s) of contamination. The root cause analysis should evaluate potential sources and explain the basis for their elimination. If the likely source of contamination cannot be identified, then the root cause analysis should thoroughly investigate and evaluate all potential sources, implemented controls, and problems.
Actions could include: an assessment of current sanitation monitoring procedures; a review of pathogen control measures included in HACCP plans; a review of cleaning and sanitizing chemicals and procedures; an evaluation of controls for cross contamination and adulteration opportunities; observing employee practices and monitoring procedures; evaluating existing employee health controls and their implementation; evaluating the effectiveness of existing environmental monitoring programs; extensive and robust environmental sampling to identify potential areas of contamination; interviewing and observing sanitation and production personnel; reviewing traffic patterns and equipment layout; evaluating supplier’s growing conditions and harvesting practices; investigating water treatment, ice-making, and plumbing within the facility; investigating sanitation controls for outside sources of water and ice; reviewing responses to identified problems or inadequacies; and reviewing records and written procedures.

2. Corrective actions taken to address the likely or potential sources and routes of contamination identified in the root cause analysis. The corrective actions should provide details on the controls implemented to prevent future adulteration based on the root cause analysis.
Actions could include: intensified cleaning and sanitizing of the facility with disassembly of equipment and robust environmental sampling to verify effectiveness of cleaning and sanitizing; increased frequency of sanitation monitoring; implementation of source controls to prevent the introduction of pathogens; evaluation and modification of existing sanitation procedures; development of comprehensive sanitation control and equipment maintenance procedures; employee training in the principles of sanitary practices and food safety; and process flow or building structure modifications.

3. Environmental monitoring program that includes scientifically robust routine sampling to verify the successful exclusion of pathogens from areas where cross contamination and adulteration are likely to occur and identify contamination when present. The plan should include processing area floor diagrams identifying equipment and collection sites, the type of sampling done, number of samples collected, frequency of collection, identification of sampling equipment, instructions for the collection of samples, test methodology, and corrective actions.

4. Written standard sanitation operating procedures (SSOPs), routine training records, validation studies, and corrective action plans.

5. Five production codes or five days of monitoring records demonstrating the implementation of routine controls/corrective actions for:

a) Sanitation monitoring records as required by 21 CFR 123.11
b) Environmental monitoring test results for pathogens.
c) Critical control point (CCP) monitoring records and the associated seafood HACCP plan(s) listing those CCPs relevant to the control of pathogens.

In addition, it may be necessary for the FDA to gather additional observational evidence to determine that the conditions that gave rise to the appearance of the violation have been resolved. Depending on the facts and circumstances, this may include an inspection of the facility by the FDA, a foreign competent authority, or a third-party auditor.
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 DWPE under the Red List of this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination under the Red List of this alert will be referred by DIO to HFP/Import Enforcement Branch for evaluation.
Questions or issues involving import operations, contact 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 other additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

                                                                                                                                                                  

Various seafood products (Product codes: 16[][][][])

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]

OASIS CHARGE CODE: MFR INJ

AND

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [INSANITARY MANUFACTURING, PROCESSING OR PACKING, Section 801(a)(1)]

OASIS CHARGE CODE: MFR INSAN

Desc: Cold Smoked Salmon

Notes: Product appears to be adulterated within the meaning of 402(a)(4) of the Act and that the conditions in which they were prepared, packed, or held resulted in their contamination with Listeria Monocytogenes, that rendered them injurious to health.                                                                                                                                                  

Desc: All Seafood