FDA Issues Warning to Importer for Failing to Actually Verify Supplier Performance

FDA issues a Warning Letter to a Florida importer, Eurobread Inc. dba First Harvest, after that product the firm imports was involved in a Salmonella outbreak.  The February 2025 Salmonella outbreak was linked to mini pastries imported from Italy.

So while the importer did have a FSVP in place and they did have paperwork from that supplier, they did not verify performance.

"The records for your (b)(4), included third party audit certificates dated (b)(4); customer letter dated 30/01/2025; egg pasteurization declaration dated 26/09/2024; manufacturer’s declaration dated 02/10/2024; heat treatment for egg products dated 6 Giugno 2024; and a (b)(3)(A). However, you did not document your review and assessment of these records, or an evaluation of your foreign suppliers’ performance and the risk posed by a food conducted under 21 CFR 1.505(a), as required by 21 CFR 1.505(b)."

"..before importing a food from a foreign supplier you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities before importing a food from a foreign supplier, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor. Additionally, for food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States), in accordance with 21 CFR 1.506(e)(1)(i)(B). "

I think this is a common issue with regulations in general.  Companies feel compliance is just collecting the paperwork without understanding and then implementing meaningful verification.  The goal of the regulation is that companies do more than collect the paperwork, but ensure that the supplier is performing. 


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eurobread-inc-dba-first-harvest-705728-07312025
Eurobread Inc. dba First Harvest
MARCS-CMS 705728 — July 31, 2025

New Jersey Establishment Recalls Meat Product with False Establishment Number

Sabrositos Hondurenos, LLC, in Edison, N.J., is recalling approximately 32,000 pounds of various meat products that were produced without the benefit of federal inspection bearing labels with a false USDA mark of inspection.  The products subject to recall bear false marks of inspection with establishment number "EST. 1785," which does not exist. These items were shipped to retail locations and restaurants nationwide.  The problem was discovered during routine FSIS surveillance activities when FSIS investigators observed various meat products in commerce bearing false marks of federal inspection.

https://www.fsis.usda.gov/recalls-alerts/sabrositos-hondurenos-llc-recalls-various-meat-products-produced-without-benefit
Sabrositos Hondurenos, LLC, Recalls Various Meat Products Produced Without Benefit of Inspection
FSIS Announcement

WASHINGTON, Aug. 20, 2025 – Sabrositos Hondurenos, LLC, in Edison, N.J., is recalling approximately 32,000 pounds of various meat products that were produced without the benefit of federal inspection bearing labels with a false USDA mark of inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. As more information becomes available, FSIS may update the product list and labels with additional items. Any product bearing the false establishment number “Est. 1785” should be considered misbranded and unsafe to eat.

NC Firm Recalls Raw Pet Food After State Lab Testing Finds Pathogens

Viva Raw LLC, Charlotte, NC is voluntarily recalling two lots of dog and cat foods due to contamination with Salmonella and Listeria monocytogenes.  The potential for contamination was identified after routine testing was conducted by the North Carolina Department of Agriculture. Only products from Lots 21495 and 21975 are affected. No illnesses in dogs, cats, or humans related to these lots have been reported to date.

The company website discusses food safety and how they use bacterial cultures (in an attempt) to eliminate pathogens.

The products were distributed between July 2, 2025 and August 21, 2025 directly to consumers nationwide and to a small number of select retailers in NY, IL, SC, FL, KS, CA, and AZ.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viva-raw-issues-voluntary-recall-two-lots-dog-cat-foods-due-salmonella-and-listeria-monocytogenes
Viva Raw Issues Voluntary Recall of Two Lots of Dog an Cat Foods Due to Salmonella and Listeria Monocytogenes Contamination
Summary
Company Announcement Date:  August 25, 2025
FDA Publish Date:  August 25, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella and Listeria monocytogenes contamination
Company Name:  Viva Raw LLC.
Brand Name:  Viva
Product Description:  Ground Beef for Dogs and Ground Chicken for Dogs and Cats

Texas Firm Recalls Ice Cream - Wrong Carton, Right Lid, Undeclared Allergens

Blue Bell Ice Cream, Brenham, TX, is voluntarily recalling a limited quantity of Moo-llennium Crunch Ice Cream half gallon packaged in a Chocolate Chip Cookie Dough carton produced in its Brenham, Texas, plant because of undeclared almond, walnut, and pecan. The recalled  product was mistakenly packaged in Chocolate Chip Cookie Dough ice cream cartons with a Moo-llennium Crunch lid. 

A Blue Bell employee discovered the incorrect packaging on two half gallons while restocking a retailer. No illnesses or adverse reactions have been reported to date. No other incorrect packaging has been discovered or reported to date.

There seems to have been many recalls such as this where the cap or lid does not match the carton.  A stout preventive control at the point of packaging to check this type of thing can go a long way in preventing this type of issue.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-bell-ice-cream-issues-allergy-alert-undeclared-almond-walnut-and-pecan-moo-llennium-crunch-ice
Blue Bell Ice Cream Issues Allergy Alert on Undeclared Almond, Walnut, and Pecan in Moo-llennium Crunch Ice Cream Packaged in a Chocolate Chip Cookie Dough Half Gallon Carton with a Moo-llennium Crunch Ice Cream Lid
Summary
Company Announcement Date:  August 22, 2025
FDA Publish Date:  August 22, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almond, walnut, and pecan
Company Name:  Blue Bell Creameries, L.P.
Brand Name:  Blue Bell
Product Description:  Ice Cream

Two Seafood Distributors Issue Recalls for Shrimp from Indonesia with Potential Cesium Contamination

Two seafood distributors are recalling frozen shrimp after FDA issued a warning on August 19th for shrimp from Indonesia that may have potential contamination with a radionuclide cesium-137.   Southwind Foods, LLC of Carson, California is voluntarily recalling a limited quantity of Frozen Shrimp and Beaver Street Fisheries, LLC of Jacksonville, FL is voluntarily recalling a limited quantity of Great Value Frozen Raw Shrimp EZ-Peel & Deveined Tail-On 21-25 Per lb 

FDA stated: “At this time, no product that has tested positive or alerted for Cesium-137 (Cs-137) has entered the U.S. commerce. FDA is working with distributors and retailers that received product from PT. Bahari Makmur Sejati after the date of first detection of Cs-137 by Customs & Border Protection (CBP), but from shipments that did not alert for Cs-137, to recommend that firms conduct a recall. In conjunction with other information, FDA determined that  product from PT. Bahari Makmur Sejati violates the Federal Food, Drug, & Cosmetic Act in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with Cs-137 and may pose a safety concern.”


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/beaver-street-fisheries-llc-recalls-great-value-frozen-raw-shrimp-because-possible-health-risk
Beaver Street Fisheries, LLC Recalls Great Value Frozen Raw Shrimp Because of Possible Health Risk
Summary
Company Announcement Date: August 22, 2025
FDA Publish Date:   August 22, 2025
Product Type:  Food & Beverages  Shellfish
Reason for Announcement:  Possible contamination with radionuclide (Cesium-137)
Company Name:  Beaver Street Fisheries, LLC
Brand Name:  Great Value
Product Description:  Frozen Raw Shrimp

FDA Issues Warning For Indonesian Shrimp After One Shipment Tests Positive for Cesium (Cs-137)

FDA is actively investigating reports of Cesium-137 (Cs-137) contamination in shipping containers and frozen shrimp products processed by PT. Bahari Makmur Sejati (doing business as BMS Foods) of Indonesia. The U.S. Customs & Border Protection (CBP) alerted FDA to the detection of Cs-137 in shipping containers at four U.S. ports (Los Angeles, Houston, Savannah, and Miami). FDA collected multiple samples for radionuclide analysis, with results confirming the presence of Cs-137 in one sample of breaded shrimp. All containers and product testing positive or alerting for Cs-137 have been denied entry into the country. 

Cs-137 is a radioisotope of cesium that is man-made through nuclear reactions and because it is widespread worldwide, trace amounts of Cs-137 can be found in the environment, including soil, food, and air. FDA food monitoring focuses on radioisotopes (radionuclides) that are not normally present and are generally the result of human activities. Any unexpected finding of Cs-137 in a food product is evaluated to determine if follow up action is warranted on a case-by-case basis. After being alerted to the contamination of shipping containers detected by CBP, FDA initiated sampling of products which included five different shrimp products from PT. Bahari Makmur Sejati, one of which was a sample of frozen breaded shrimp. FDA's laboratory confirmation of Cs-137 in the breaded shrimp had detectable levels of Cs-137 present at 68.48 Bq/kg +/- 8.25 Bq/kg. There was no detectable Cs-137 in the other products tested; however, this does not rule out contamination.

This single shipment of imported frozen shrimp from PT. Bahari Makmur Sejati where Cs-137 was detected  did not enter U.S. commerce.   Although testing to date has not confirmed the presence of contamination in any product in commerce, the product posted on the Warning appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with Cs-137 and may pose a safety concern. To date, FDA has learned that Walmart has received implicated raw frozen shrimp, imported after the date of first detection of Cs-137 by CBP, but from shipments that did not alert for Cs-137. FDA has recommended Walmart recall this product.

Consumers should not eat or serve certain lots of Great Value raw frozen shrimp sold at Walmart stores in AL, AR, FL, GA, KY, LA, MO, MS, OH, OK, PA, TX, and WV:


https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-public-not-eat-sell-or-serve-certain-imported-frozen-shrimp-indonesian-firm
FDA Advises Public Not to Eat, Sell, or Serve Certain Imported Frozen Shrimp from an Indonesian Firm
Frozen shrimp imported from PT. Bahari Makmur Sejati is in violation of the Federal Food, Drug, & Cosmetic Act. FDA’s investigation is ongoing.

Ohio Firm Recalls Cheese Product After Product Tests Positive for Listeria

The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling 246.5 Lbs. of 100% Grass-fed Pepper Jack Cheese, sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, 2.5 Lbs. of Horseradish Flavored Cheese, sold in 8 oz. packages, 640 Lbs. of Monterey Jack Cheese sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, and 4,544.5 Lbs. of White Cheddar Cheese sold in 40 Lb. loaves because of potential contamination with Listeria monocytogenes

The recall was initiated after product testing by the company revealed the presence of Listeria monocytogenes in the products. Production was suspended while the company investigated the source of the contamination which was determined to be from environmental contamination that migrated to food-contact areas of the production process.

The recalled products were produced on June 16, 2025, June 24, 2025, and July 16th, and distributed in the state of Ohio between July 14, 2025 and August 7, 2025.  There have been no reports of illness to date associated with consumption of these products.

So did an environmental positive test trigger the company to test product?  

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/middlefield-original-cheese-co-op-recalls-100-grass-fed-pepper-jack-cheese-and-horseradish-flavored
Middlefield Original Cheese Co-Op Recalls 100% Grass-Fed Pepper Jack Cheese and Horseradish Flavored Cheese Due to Possible Listeria monocytogenes Contamination
Summary
Company Announcement Date:  August 18, 2025
FDA Publish Date:  August 18, 2025
Product Type:  Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential contamination with Listeria monocytogenes
Company Name:  Middlefield Original Cheese Co-op
Brand Name:  Middlefield Original Cheese Co-op/Copia Collective/Farmers Cheese
Product Description:  Cheese

NY Firm Recalls Imported Brie Due to Potential for Listeria

FROMI USA of New York, NY is recalling 12 Cases of Brie Royal Faucon 1kg, because they have the potential to be contaminated with Listeria monocytogenes.  The recall was initiated after the foreign manufacturer of this cheese was notified by its health authorities of the potential contamination of some of its products with Listeria monocytogenes.

The Brie Royal Faucon 1kg was distributed to Cheese Plate Park Slope LLC, located at 400 7th Avenue, 11215 Brooklyn NY. The recalled cheese was then cut and sold to customers from Cheese Plate Brooklyn - Park Slope LLC., and Cheese Plate Brooklyn :

No illnesses have been reported to date related to the consumption of this product within the United States.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fromi-usa-recalls-brie-royal-faucon-1kg-because-possible-health-risk
Fromi USA Recalls Brie Royal Faucon 1kg Because of Possible Health Risk
Summary
Company Announcement Date:  August 14, 2025
FDA Publish Date:  August 14, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential contamination with Listeria monocytogenes
Company Name:  Fromi USA
Brand Name:  Brie Royal Faucon
Product Description:  Brie Royal Faucon Cheese

Retailer Recalls Imported Cheese After Foreign Supplier Issue Listeria Concern

Wegmans Food Markets, Inc. is recalling Wegmans Medium Camembert Soft Ripened Cheese, and various products containing this cheese, because it has the potential to be contaminated with Listeria monocytogenes.  The cheese was supplied to Wegmans by Estancia Holdings of Cumming, Georgia, who initiated a recall after the company was notified by their French supplier that three shipments they received may be contaminated with Listeria monocytogenes.

The affected products were sold in the cheese department at all Wegmans stores located in Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, Virginia, and Washington, D.C.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wegmans-food-markets-inc-recalls-various-wegmans-camembert-soft-ripened-cheese-products-because
Wegmans Food Markets, Inc. Recalls Various Wegmans Camembert Soft Ripened Cheese Products Because of Possible Health Risk
Summary
Company Announcement Date:  August 12, 2025
FDA Publish Date:  August 12, 2025
Product Type:  Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential Foodborne Illness - Listeria monocytogenes
Company Name:  Wegmans New York
Brand Name:  Wegmans
Product Description:  Cheeses