Import Alert 16-137
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 16-137
Published Date: 01/28/2026
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Seafood Due to Viral Contamination"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 07/18/2024 updates the name of the alert, reason for alert, guidance section, product description, and charge section. Changes to the import alert are bracketed by asterisks (***).
In May 2017, the FDA analyzed frozen raw tuna products from a firm and found that they contained hepatitis A virus. Follow up FDA screening found a second firm's raw frozen tuna contained hepatitis A virus.
***In April 2024, an outbreak of norovirus that resulted in 39 cases of illness in two states, was linked to frozen raw oysters on the half-shell. In May 2024, FDA detected norovirus in a sample of frozen “Oysters Rockefeller” a value-added product that consisted of oysters on the half shell with sauce and spinach. This sample was collected as part of the outbreak investigation. Since the explicit intent is that this value-added product will be cooked by the end consumer, this product falls outside the scope of the National Shellfish Sanitation Program (NSSP) and is directly under FDA jurisdiction and subject to 21 CFR 123. The product was produced by a processor who was associated with the firm linked to the illness and the production date was within the date range of illness.***
Hepatitis A virus ***and norovirus are*** primarily transmitted by person-to-person contact through the fecal-oral route and by the consumption of contaminated food or water. Foods can be contaminated by infected workers in food production facilities/processing plants and restaurants. No known non-human sources of the virus exist. FDA believes that hepatitis A virus ***and norovirus*** contaminated seafood is a result of gross insanitary conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated ***harvest or process water.***
In May 2017, the FDA analyzed frozen raw tuna products from a firm and found that they contained hepatitis A virus. Follow up FDA screening found a second firm's raw frozen tuna contained hepatitis A virus.
***In April 2024, an outbreak of norovirus that resulted in 39 cases of illness in two states, was linked to frozen raw oysters on the half-shell. In May 2024, FDA detected norovirus in a sample of frozen “Oysters Rockefeller” a value-added product that consisted of oysters on the half shell with sauce and spinach. This sample was collected as part of the outbreak investigation. Since the explicit intent is that this value-added product will be cooked by the end consumer, this product falls outside the scope of the National Shellfish Sanitation Program (NSSP) and is directly under FDA jurisdiction and subject to 21 CFR 123. The product was produced by a processor who was associated with the firm linked to the illness and the production date was within the date range of illness.***
Hepatitis A virus ***and norovirus are*** primarily transmitted by person-to-person contact through the fecal-oral route and by the consumption of contaminated food or water. Foods can be contaminated by infected workers in food production facilities/processing plants and restaurants. No known non-human sources of the virus exist. FDA believes that hepatitis A virus ***and norovirus*** contaminated seafood is a result of gross insanitary conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated ***harvest or process water.***
Guidance:
Divisions may detain without physical examination, shipments of fresh or frozen raw seafood from the firms identified on the Red List of this Alert.
This alert EXCLUDES LACF (canned and pouched) seafood products (i.e. products with a scheduled process on file with CFSAN per 21 CFR 113) ***and raw molluscan shellfish under the NSSP and covered by Import Alert #16-50.***
*** The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by 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). ***
***Products from firms identified on the Red List should be detained using the POISONOUS, INSANITARY, AND MFR INSAN charge codes.
Products from firms identified on the Yellow List should be detained using the POISONOUS charge code.***
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Requests for removal from detention without physical examination (DWPE) under this Import Alert is a two-step process. First, the firm must apply for removal from the Red List and subsequent addition to the Yellow List. ***
*** ***
NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of ***hepatitis A virus or norovirus*** to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801 (a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.
Per FDA's regulatory procedures manual (RPM) Chapter 9-8, "Detention without Physical Examination (DWPE)," in order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as ***corrective actions*** taken to prevent violations in future shipments.
***The petition for removal from the Red List (addition to the Yellow list), should be in English and should include the following:
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; interviewing and observing sanitation and production personnel; 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. Written corrective actions taken, based on the root cause analysis, to eliminate the source of the contamination, including sanitation standard operating procedures (SSOPs)that are intended to prevent reoccurrence of contamination, the monitoring records documenting the implementation of the SSOPs, and verification procedures. SSOPs may include the following applicable items:
a. Water safety;
b. Controls for worker health and hygiene (e.g., training and monitoring for proper hand washing, monitoring of hand and boot dips, monitoring of employees for symptoms, hepatitis A vaccine);
c. Maintenance of hand washing and toilet facilities;
d. Sanitary facilities in receiving and processing;
e. Condition and cleanliness of food contact surfaces (e.g., visual inspection of food and hand contact surfaces prior to use, repair or removal of dirty or damaged surfaces);
f. Maintenance program for cleaning and sanitizing equipment;
g. Sanitary transportation practices
3. 5 days' worth of monitoring records. ***
***Once FDA has reviewed the submitted documents and finds them to be adequate, the firm will then be added to the Yellow List. The purpose of the Yellow List is to alert the field of the firms for which the FDA has agreed to allow to ship product to the United States. After being added to the Yellow List, the firm will still be subjected to DWPE, however, they will be permitted to obtain individual release of entries, if non-violative private laboratory analytical reports are provided which demonstrate the absence of adulteration. Once the firm has satisfied the requirements for removal from DWPE with a minimum of five consecutive non-violative commercial shipments, the firm and/or a representative should submit a request to DIO to have the firm removed from the Yellow List, which removes the firm from being subjected to DWPE. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7.***
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 forward to the following email address: 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 EXCLUDES LACF (canned and pouched) seafood products (i.e. products with a scheduled process on file with CFSAN per 21 CFR 113) ***and raw molluscan shellfish under the NSSP and covered by Import Alert #16-50.***
*** The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by 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). ***
***Products from firms identified on the Red List should be detained using the POISONOUS, INSANITARY, AND MFR INSAN charge codes.
Products from firms identified on the Yellow List should be detained using the POISONOUS charge code.***
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Requests for removal from detention without physical examination (DWPE) under this Import Alert is a two-step process. First, the firm must apply for removal from the Red List and subsequent addition to the Yellow List. ***
*** ***
NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of ***hepatitis A virus or norovirus*** to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801 (a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.
Per FDA's regulatory procedures manual (RPM) Chapter 9-8, "Detention without Physical Examination (DWPE)," in order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as ***corrective actions*** taken to prevent violations in future shipments.
***The petition for removal from the Red List (addition to the Yellow list), should be in English and should include the following:
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; interviewing and observing sanitation and production personnel; 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. Written corrective actions taken, based on the root cause analysis, to eliminate the source of the contamination, including sanitation standard operating procedures (SSOPs)that are intended to prevent reoccurrence of contamination, the monitoring records documenting the implementation of the SSOPs, and verification procedures. SSOPs may include the following applicable items:
a. Water safety;
b. Controls for worker health and hygiene (e.g., training and monitoring for proper hand washing, monitoring of hand and boot dips, monitoring of employees for symptoms, hepatitis A vaccine);
c. Maintenance of hand washing and toilet facilities;
d. Sanitary facilities in receiving and processing;
e. Condition and cleanliness of food contact surfaces (e.g., visual inspection of food and hand contact surfaces prior to use, repair or removal of dirty or damaged surfaces);
f. Maintenance program for cleaning and sanitizing equipment;
g. Sanitary transportation practices
3. 5 days' worth of monitoring records. ***
***Once FDA has reviewed the submitted documents and finds them to be adequate, the firm will then be added to the Yellow List. The purpose of the Yellow List is to alert the field of the firms for which the FDA has agreed to allow to ship product to the United States. After being added to the Yellow List, the firm will still be subjected to DWPE, however, they will be permitted to obtain individual release of entries, if non-violative private laboratory analytical reports are provided which demonstrate the absence of adulteration. Once the firm has satisfied the requirements for removal from DWPE with a minimum of five consecutive non-violative commercial shipments, the firm and/or a representative should submit a request to DIO to have the firm removed from the Yellow List, which removes the firm from being subjected to DWPE. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7.***
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 forward to the following email address: 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.
***
Product Description:
***SEAFOOD, FRESH and/or FROZEN***
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]
OASIS charge code – POISONOUS***
And,
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]
OASIS charge code – INSANITARY
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. [ADULTERATION, Section 402(a)(4)]
OASIS charge code – MFR INSAN
OASIS charge code – POISONOUS***
And,
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]
OASIS charge code – INSANITARY
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. [ADULTERATION, Section 402(a)(4)]
OASIS charge code – MFR INSAN
Countries
MULTIPLE COUNTRIES
-
(16 - - - --) Fishery/Seafood ProductsDesc: RAW SEAFOOD; FRESH and/or FROZEN
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
KOREA (THE REPUBLIC OF)
JBR
Date Published : 08/20/2024
2119 Dosanilju-Ro , Dosan-Myeon
, Tongyeong,
Gyeongsangnam KOREA (THE REPUBLIC OF)
16 E - - 03 Oysters
Date Published: 08/20/2024
Desc: Oysters Rockefeller
Notes: Problem: Norovirus; raw oysters not subject to DWPE. Published 08/20/2024
16 W - - 03 Meals separated in serving container w/shellfish (clams, oysters, mussels, scallops, etc.)
Date Published: 08/20/2024
Desc: Oysters Rockefeller
Notes: Problem: Norovirus; raw oysters not subject to DWPE. Published 08/20/2024
16 X - - 32 Oysters, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/20/2024
Desc: Oysters Rockefeller
Notes: Problem: Norovirus; raw oysters not subject to DWPE. Published 08/20/2024
KOREOYS
Date Published : 08/20/2024
Dosaniljuro 2119, Dosan , Myeon, Kyeongsangnam
, Tongyoung,
KOREA (THE REPUBLIC OF)
16 E - - 03 Oysters
Date Published: 08/20/2024
Desc: Oysters Rockefeller
Notes: Problem: Norovirus; raw oysters not subject to DWPE. Published 08/20/2024
16 W - - 03 Meals separated in serving container w/shellfish (clams, oysters, mussels, scallops, etc.)
Date Published: 08/20/2024
Desc: Oysters Rockefeller
Notes: Problem: Norovirus; raw oysters not subject to DWPE. Published 08/20/2024
16 X - - 32 Oysters, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/20/2024
Desc: Oysters Rockefeller
Notes: Problem: Norovirus; raw oysters not subject to DWPE. Published 08/20/2024
MEXICO
ARTURO MANUEL ROMANDIA TOYOS
Date Published : 01/11/2019
Caguama 332 , Col. Las Delicias
, Guaymas,
Sonora MEXICO
16 J - - 01 Crab
Date Published: 01/11/2019
Desc: Crab
Congeladora Don Crispin S.A. de C.V.
Date Published : 01/11/2019
Lote 7 Manzana 33 S/N , Las Playitas 1
, Guaymas,
MX-SON MEXICO
16 J - - 01 Crab
Date Published: 01/11/2019
Desc: Crab
PHILIPPINES
Malalag Bay Aquaculture & Processing Corp.
Date Published : 03/06/2025
Market 4, Fishport Complex , Barangay Tambler
, General Santos City,
South Cotabato PHILIPPINES
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/06/2025
Desc: Tuna
Notes: Problem(s):
Hepatitis A virus
16 A - - 53 Milkfish
Date Published: 10/23/2025
Desc: Milkfish
Notes: Problem(s):
Hepatitis A virus
16 S - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, etc.), Cold Smoked, Fish
Date Published: 10/23/2025
Desc: Tuna
Notes: Problem(s):
Hepatitis A virus
SANTA CRUZ SEAFOODS, INC.
Date Published : 02/08/2018
Gen. Santos Fishport Complex , Tambler
, South Cotabato,
Socsargen PHILIPPINES
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 02/08/2018
Desc: Tuna
Notes: Problem(s):
Hepatitis A virus
16 A - - 53 Milkfish
Date Published: 10/23/2025
Desc: Milkfish
Notes: Problem(s):
Hepatitis A virus
16 S - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, etc.), Cold Smoked, Fish
Date Published: 10/23/2025
Desc: Tuna
Notes: Problem(s):
Hepatitis A virus
VIETNAM
Sustainable Seafood Co., Ltd.
Date Published : 12/13/2017
Lot F5-6 Suoi Dau Industrial Zone
, Cam Lam,
Khanh Hoa VIETNAM
16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 12/13/2017
Desc: fresh or frozen raw tuna