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Import Alert 16-137: Detention without physical examination of seafood due to viral contamination

FDA last published FDA alert page

As of October 26, 2026, FDA Import Alert 16-137 (Seafood Due to Viral Contamination) lists 6 firms on its red list and 1 on its yellow list in 4 countries, covering seafood, fresh and/or frozen; 0 firms were added and 0 removed in the last 90 days.

Data from FDA public records, last checked . Request a correction

6
firms on the red list
1
firms on the yellow list
4
countries
0
added in the last 90 days
0
removed in the last 90 days

What changed in the last 90 days

Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.

Removed from Import Alert 16-137

SupplierRadar has recorded no removals from Import Alert 16-137 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.

Added to Import Alert 16-137

No firm was added to Import Alert 16-137 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 16-137, by country

7 listings in 4 countries. Each name links to the firm's FDA record history; the date is the one FDA published on the alert.

Listings by country

Import alert listings by country
CountryRed listYellow listTotal
Mexico22
Philippines112
South Korea22
Vietnam11
Firms in Mexico on Import Alert 16-137
FirmListProductsDate published
Arturo Manuel Romandia ToyosGuaymasRedCrab
Congeladora Don Crispin S.A. de C.V.GuaymasRedCrab
Firms in Philippines on Import Alert 16-137
FirmListProductsDate published
Malalag Bay Aquaculture & Processing Corp.General Santos CityYellowTuna; Milkfish
Santa Cruz Seafoods, Inc.South CotabatoRedTuna; Milkfish
Firms in South Korea on Import Alert 16-137
FirmListProductsDate published
JbrTongyeongRedOysters Rockefeller
KoreoysTongyoungRedOysters Rockefeller
Firms in Vietnam on Import Alert 16-137
FirmListProductsDate published
Sustainable Seafood Co., Ltd.Cam LamRedfresh or frozen raw tuna

Refusal charges named on this alert

FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.
Charge codes named on Import Alert 16-137
Charge codeMeaningRefusal lines since 2016
MFR INSANInsanitary manufacturing, processing or packing3,070
POISONOUSPoisonous or deleterious substance2,420
INSANITARYPrepared, packed or held under insanitary conditions898

What the alert covers and why FDA issued it

FDA's wording, with FDA's change markers removed.
Official title
Detention Without Physical Examination of Seafood Due to Viral Contamination
Product scope
Seafood, fresh and/or frozen
Last published

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.

FDA Import Alert 16-137, Reason for AlertRead it on FDA
Read the rest of the reason

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.

Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.

Questions about Import Alert 16-137

What is Import Alert 16-137?
Import Alert 16-137, “Detention without physical examination of seafood due to viral contamination”, is an FDA import alert. FDA may detain seafood, fresh and/or frozen from the firms on its red list without physical examination; FDA last published the alert on July 2, 2026.
Which firms are on Import Alert 16-137?
As of October 26, 2026, 7 firms are listed on Import Alert 16-137 in 4 countries; the most listings are in Mexico (2), Philippines (2) and South Korea (2). The full table, grouped by country, is below on this page and every firm links to its record.
How do firms get off Import Alert 16-137?
A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 16-137; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 16-137?
The charge section of Import Alert 16-137 names MFR INSAN (insanitary manufacturing, processing or packing), POISONOUS (poisonous or deleterious substance) and INSANITARY (prepared, packed or held under insanitary conditions). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
Which firms were added to Import Alert 16-137 recently?
No firm was added to Import Alert 16-137 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 16-137 recently?
SupplierRadar has recorded no removals from Import Alert 16-137 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.