MI Cheese Company Recalls Brie and Camembert Cheese After Linked to Listeria Outbreak

FDA is investigating a Listeria outbreak that has been linked to Brie and Camembert soft cheese products manufactured by Old Europe Cheese, Inc. of Benton Harbor, MI, and sold at various retailers under multiple labels and brands, including Reny Picot.  According to CDC, there have been 6 cases so far, with 5 of those people being hospitalized.

The processor, Old Europe Cheese, Inc has recalled all Old Europe Cheese Brie and Camembert products with best by dates through 12/14/2022 . There are over 20 brand named products that were distributed from August 01, 2022 through September 28, 2022 and were available at supermarkets, wholesale and retail stores nationwide and Mexico; retailers include Albertsons, Safeway, Meijer, Harding’s, Shaw’s, Price Chopper, Market Basket, Raley’s, Save Mart, Giant Foods, Stop & Shop, Fresh Thyme, Lidl, Sprouts, Athenian Foods, Whole Foods." 


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-brie-and-camembert-soft-cheese-products-september-2022
Outbreak Investigation of Listeria monocytogenes: Brie and Camembert Soft Cheese Products (September 2022)
Do not eat, sell, or serve recalled Brie and Camembert soft cheese products from Old Europe Cheese, Inc. FDA’s outbreak investigation is ongoing.

Case Counts
Total Illnesses: 6
Hospitalizations: 5
Deaths: 0
Last illness onset: August 5, 2022
States with Cases: CA, GA, MA, MI, NJ, TX
Product Distribution: Nationwide

Parasite - Incidence of Anisakis in Japan

 An interesting report in this month's Emerging Infectous Disease involves Anisakis, a parasite commonly linked with raw or undercooked seafood, and its incidence in Japan, a country that consumes a large amount of raw seafood in the form of sushi and sashimi.  Researchers estimated that the annual incidence is close to 20,000 cases per year.  I think that many people assume that sushi and sushimi represents zero risk, especially when we think of Japan.  This is not the case.

"In Japan, A. simplex s.s. nematodes are responsible for the highest incidence of anisakiasis, whereas the species A. pegreffii is the leading cause of anisakiasis in Europe and South Korea (2). A. simplex s.s. nematodes penetrate the muscles of various fish species at a higher rate than A. pegreffii (11), which could partly explain the smaller proportion of A. pegreffii anisakiasis cases in Japan because A. pegreffii nematodes are often removed with fish viscera during the preparation of sushi and sashimi. Furthermore, fish habitat can corroborate the difference in predominant anisakid nematode species between South Korea and Japan; A. simplex s.s.–carrying fish are predominant in the Pacific side of Japan, whereas A. pegreffii–carrying fish are more common in the Sea of Japan and the East China Sea, located between South Korea and Japan (11)"

"As preventive measures, the government of Japan has repeatedly instructed local establishments (e.g., restaurants, fish mongers, and grocery stores) and consumers to freeze seafood at −20°C for at least 24 hours before consuming it raw or to remove anisakid nematodes during cooking."   In the US, there is no regulated standard for 'sushi grade seafood' but this term generally means that that the seller has determined that the fish is acceptable for eating raw based on several factors, including if that the fish has been frozen according to a validated freezing schedule for parasite reduction.

Anisakiasis, the disease caused by infection of this worm.  According to the CDC, "when certain infected marine mammals (such as whales or sea lions) defecate into the sea, eggs are released and become infective larvae while in the water. These larvae are ingested by crustaceans, which are then eaten by fish or squid. When humans eat raw or undercooked infected fish or squid, they ingest nematode larvae. Once inside the human body, the larvae can invade the gastrointestinal tract. Eventually, the parasite dies and produces an inflamed mass in the esophagus, stomach, or intestine."

"Some people experience a tingling sensation after or while eating raw or undercooked fish or squid. This is actually the worm moving in the mouth or throat. These people can often extract the worm manually from their mouth or cough up the worm and prevent infection. Also, some people experience vomiting as a symptom and this can often expel the worm from the body."

Anisakiasis Annual Incidence and Causative Species, Japan, 2018–2019 - Volume 28, Number 10—October 2022 - Emerging Infectious Diseases journal - CDC
ISSN: 1080-6059
Emerging and Infectious Disease Journal
Volume 28
Number 10—October 2022
Anisakiasis Annual Incidence and Causative Species, Japan, 2018–2019
Hiromu SugiyamaComments to Author , Mitsuko Shiroyama, Ikuyo Yamamoto, Takashi Ishikawa, and Yasuyuki Morishima

Author affiliations: National Institute of Infectious Diseases, Tokyo, Japan (H. Sugiyama, I. Yamamoto, Y. Morishima); Azabu University, Kanagawa, Japan (M. Shiroyama); BML, Inc., Saitama, Japan (T. Ishikawa)

Abstract

Using data from 2018–2019 health insurance claims, we estimated the average annual incidence of anisakiasis in Japan to be 19,737 cases. Molecular identification of larvae revealed that most (88.4%) patients were infected with the species Anisakis simplex sensu stricto. Further insights into the pathogenesis of various anisakiasis forms are needed.

Ill. Establishment Recalls 2 Months of Production After USDA Testing Finds Listeria

Behrmann Meat and Processing Inc., an Albers, Ill. establishment, is recalling approximately 87,382 pounds of various ready-to-eat (RTE) meat products that may be adulterated with Listeria monocytogenes.  The various RTE meat items were produced from July 7, 2022, to Sept. 9, 2022.  The problem was discovered through product and environmental testing performed by FSIS and the establishment, which identified Listeria monocytogenes in the processing environment and in products produced by the establishment.

With a wide time frame of recalled products and the fact that FSIS testing "identified Listeria monocytogenes in the processing environment and in products produced by the establishment", one could guess that this is not just an incidental contamination issue.  The company website indicates the establishment operates a retail store as well as producing product for wholesale.

https://www.fsis.usda.gov/recalls-alerts/behrmann-meat-and-processing-inc--recalls-various-ready-eat-meat-products-due
Behrmann Meat and Processing Inc. Recalls Various Ready-to-Eat Meat Products Due to Possible Listeria Contamination

BEHRMANN MEAT & PROCESSING, INC.

FSIS Announcement

WASHINGTON, Sept. 24, 2022 – Behrmann Meat and Processing Inc., an Albers, Ill. establishment, is recalling approximately 87,382 pounds of various ready-to-eat (RTE) meat products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. FSIS expects there to be additional product labels added in the near future and urges consumers to check back frequently to view updated labels.

Florida Foodservice Establishment Recalls Empanada Products When Discovered Not USDA Inspected

Empanadas Valrico Inc., a Sarasota, Fla. establishment, is recalling approximately 6,247 pounds of beef and chicken empanada products that were produced without the benefit of federal inspection.  The products subject to recall do not bear the USDA mark of inspection because Empanadas Valrico Inc. is not a federally inspected establishment. These items were shipped to retail locations in Florida.  The problem was discovered when FSIS was notified by the Florida Department of Agriculture that the frozen empanada products did not have the USDA mark of inspection and were produced in an establishment that was not inspected by USDA.

Another example of a small restaurant / catering operation that starts to distribute products without realizing that federal regulations apply.

https://www.fsis.usda.gov/recalls-alerts/empanadas-valrico-inc--recalls-beef-and-chicken-empanada-products-produced-without
Empanadas Valrico Inc. Recalls Beef and Chicken Empanada Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, Sept. 23, 2022 – Empanadas Valrico Inc., a Sarasota, Fla. establishment, is recalling approximately 6,247 pounds of beef and chicken empanada products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Salad Dressing Recalled After Mislabeling Issue Results in Undeclared Allergens

TreeHouse Foods, Inc. (NYSE: THS) is voluntarily recalling one lot of Restaurant Style Italian Dressing sold under the brand name Tuscan Garden.  This recall is being conducted because the product is labeled as Restaurant Style Italian Dressing, while some of the bottles may contain Asian Sesame Dressing. The Restaurant Style Italian Dressing label indicates the allergens egg and dairy are in the product while the Asian Sesame Dressing product contains the allergens soy and wheat.  TreeHouse Foods discovered the issue after receiving two complaints from the store level. At this time, TreeHouse has not received any reports of an allergic reaction associated with this product.

With recalled product limited to one lot code date, this would appear to be a mistake made at the point of label application...perhaps the wrong labels were mixed in with the others, or the wrong pack of labels were added to the spool.  An Allergen Preventive Control at this point would include a verification procedure to ensure that correct labels were being run.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/treehouse-foods-announces-voluntary-recall-certain-tuscan-garden-restaurant-style-italian-dressing
TreeHouse Foods Announces Voluntary Recall of Certain Tuscan Garden Restaurant Style Italian Dressing Due to Undeclared Wheat and Soy
Summary
Company Announcement Date:  September 24, 2022
FDA Publish Date:  September 24, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergen/Wheat and Soy
Company Name:  TreeHouse Foods, Inc.
Brand Name:  Tuscan Garden
Product Description:  Restaurant Style Italian Dressing

Recall of Salad Dressing Due to Undeclared Allergen Recall Expanded

VanLaw Food Products Inc. is expanding its recall (in late August) of Whole Foods Market 365 Organic Creamy Caesar Dressing because it contains undeclared Soy and Wheat allergens. The recall is being expanded to include Whole Foods Market 365 Organic Creamy Caesar Dressing with a BEST IF USED BY DATE of SEP 21 22 through JUN 06 23 and incorrect UPC Code 99482-49027.  The recalls were initiated when it was discovered the products were distributed in packaging that did not reveal the presence of Soy and Wheat allergen. The problem was caused when the back label from another product was mistakenly put on the products being recalled.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/van-law-food-products-issues-allergy-alert-undeclared-soy-and-wheat-product-expanded
Van Law Food Products Issues Allergy Alert on Undeclared Soy and Wheat in Product Expanded
Summary
Company Announcement Date: September 23, 2022FDA 

Publish Date:September 23, 2022

Product Type:Food & Beverages

Reason for Announcement:  Undeclared Soy & Wheat

Company Name:VanLaw Food Products Inc.

Brand Name:  Whole Foods Market 365Product 

Description:  Organic Creamy Caesar Dressing

MA Company Recalls Candy Corn for Undeclared Egg

Arcade Snacks of Auburn, MA is recalling its 15 ounce packages of Candy Corn because they may contain undeclared egg.  The recall was initiated after it was discovered that the egg-containing product was distributed in packaging that did not reveal the presence of egg.

So is there an candy corn formulation that contains egg or was this a completely different product that was mislabeled?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/arcade-snacks-issues-allergy-alert-undeclared-egg-candy-corn
Arcade Snacks Issues Allergy Alert on Undeclared Egg in Candy Corn
Summary
Company Announcement Date: September 23, 2022
FDA Publish Date:  September 23, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Egg
Company Name:  Arcade Snacks
Brand Name:  Arcade Snacks
Product Description:  Candy Corn

CA Produce Processor Recalling Potato Product Because of Undeclared Egg

World Variety Produce, Inc. of Verona CA is recalling specific lots of Melissa’s Brand Dutch Red Potatoes with Dijon Mustard Sauce due to an undeclared allergen egg.  It appears that the wrong sauce packet was placed in the master package.

World Variety Produce, Inc. Voluntarily Recalls Select Lots of Melissa’s Dutch Red Potatoes with Dijon Mustard Sauce Because it Contains Undeclared Egg Allergens | FDA
World Variety Produce, Inc. Voluntarily Recalls Select Lots of Melissa’s Dutch Red Potatoes with Dijon Mustard Sauce Because it Contains Undeclared Egg Allergens
Summary
Company Announcement Date: September 21, 2022
FDA Publish Date:  September 21, 2022
Product Type:  Food & Beverages  Gravy/Sauces
Reason for Announcement:  Undeclared Egg
Company Name:  World Variety Produce Inc.
Brand Name:  Melissa’s
Product Description:  Dutch Red Potatoes with Dijon Mustard Sauce

GA Company Recalls Various Fresh Salad Items After Positive Listeria Test

GHGA is recalling various products (see chart below) due to the potential to be contaminated with Listeria monocytogenes. On 9/16/22 the firm was notified by their laboratory that a single sample of a product tested positive for Listeria monocytogenes.

These products were packaged in clear plastic containers and sold primarily in Kroger stores on 9/11/22 in the produce or deli sections in the states of: Alabama, South Carolina, and Georgia. The Sell-by Date has expired, and products were previously removed from store shelves and are no longer for sale. However, products could still be in possession of consumers.

Renaissance Food Group, which operates under the name GH Foods, is located in Conley, Georgia. This organization primarily processes fresh refrigerated salads.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ghga-recalls-various-ready-eat-vegetable-products-due-possible-listeria-monocytogenes-contamination
GHGA Recalls Various Ready-To-Eat Vegetable Products Due to Possible Listeria Monocytogenes Contamination
Summary
Company Announcement Date:  September 20, 2022
FDA Publish Date:  September 20, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  GHGA
Brand Name:  GHGA
Product Description:  Ready-To-Eat Vegetable Products

CA Sprout Operation Cited for Lack of Listeria Control

The FDA inspected a sprout growing, harvesting, packing, and distributing facility, located in Sacramento, California.  FDA issued a Warning Letter with the following identified issues:

• Did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes if it is present in the growing, harvesting, packing, and holding environment 
• FDA "identified Listeria seeligeri in 1 of 102 environmental swabs (INV1177912, Sub 28). Sub 28 was collected from a joint surface between your metal sprout wash tank and metal exterior surface within your sprout growing room"
• Did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified in 21 CFR 112.147 
• Did not appropriately clean and sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required by 21 CFR
• Had inadequate sanitation practices and use of a sanitizing agent in place of conducting cleaning activities
• Personnel at the firm did not use hygienic practices 
• Did not appropriately train personnel who handle (contact) covered produce or food contact surfaces, and personnel who conduct covered activities,

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022
Sun Sen Co., Inc.

FDA Issues Warning Letter to RTE Produce Processor With Positive Listeria Environmental Samples

FDA issued a Warning Letter after inspection and environmental sampling of  a ready-to-eat (RTE) fresh-cut fruit and vegetable processing facility located in Wakefield, MA.  This "facility receives fruit and vegetables, some of which are RTE, including cantaloupe and apples, that are processed into RTE sliced, diced, and/or cubed fruit and vegetable products (e.g., cubed cantaloupe and sliced apples). The RTE fruit and vegetable products are exposed to the environment prior to packaging, where they may become contaminated with environmental pathogens such as L. monocytogenes. As evidenced by the findings of L. monocytogenes in your production environment and current inspectional findings, you did not identify and implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes" 

"FDA laboratory analysis of the environmental sample 1119291 collected on February 8, 2022, from various areas in your processing facility confirmed eight (8) of fifty-six (56) environmental swabs were positive for L. monocytogenes. Of the positive findings, three (3) swabs were collected from food-contact surfaces where RTE cantaloupe and RTE sliced apples were being prepared, including:

• Surface of the stainless-steel fruit table used for coring apples
• Blade of the yellow knife used to cut cantaloupe
• Green squeegee used for wiping the surface of the stainless-steel table where cantaloupes were being processed
• In addition, L. monocytogenes was found on a tote used for holding bulk/whole cantaloupe.

GMP issues identified during the  inspection: 

• Investigators observed employee handling practices which could lead to cross-contamination of food-contact surfaces and RTE food products including "an employee used a high-pressure hose that had contacted the floor before use and sprayed the rear wall of the main production facility during production of RTE romaine lettuce. The spray from the hose was observed contacting the floor several times and creating an aerosol and mist within the production area that was also visible in the air several feet away from the RTE romaine that was processed."
• Condensate was observed dripping from the overhead ceiling and refrigeration unit in the main production room to the floor, approximately 10 feet from where RTE diced red onion was being processed. We have previously notified you of our concerns related to condensate during FDA inspections conducted in 2018 and 2019.
• The plastic conveyer belt used for production of r butternut squash product was damaged, with rough surfaces and missing teeth.
• Several areas of flooring and surfaces around drains in the main production area were damaged, with exposed rough aggregate.
• Plastic bins/barrels used to hold RTE finished products, vegetable and fruit waste, and garbage were damaged, cracked, and chipped, with rough surfaces.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banks-square-market-corp-dba-produce-connection-631118-09022022

Banks Square Market Corp. dba The Produce Connection

MARCS-CMS 631118 — SEPTEMBER 02, 2022

Kansas Feed Mill Cited for Preventive Controls Violations in Response to Copper Toxicity Issue

FDA issued a Warning Letter to a KS feed processor after inspected by Kansas Dept of Ag.  The "KDA inspections were conducted in response to consumer complaints regarding suspected copper poisoning from sheep food that resulted in multiple sheep deaths. A sample of your “Lamb Builder 16% Lamb Creep 80869” sheep food collected by KDA on November 19, 2021 and analyzed by the Nebraska Department of Agriculture contained an elevated level of copper at 31.0 parts per million (ppm), which is a level that would cause acute toxicity in sheep.1 The recognized maximum tolerable level of copper in food for sheep is 15 ppm on a dry matter basis, assuming normal concentrations of molybdenum and sulfur".

FDA stated, "Your facility failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).  Specifically, your reliance on your prerequisite program failed to reduce the probability that an elevated level of copper will occur in your animal food in the absence of a preventive control."

FDA had issue with mycotoxin control of incoming ingredients as well as those that may form during storage.

• The "company did not identify the known or reasonably foreseeable hazards of fumonisin and deoxynivalenol (DON or vomitoxin) for all grains and their co-products you receive and use as ingredients at your facility that are susceptible to fumonisin and vomitoxin. Also, you did not evaluate the severity of the illness or injury if the hazards were to occur, or the probability that the hazards would occur in the absence of preventive controls, to determine whether the hazards require a preventive control.  Furthermore, your “Aflatoxin Testing Procedure” only includes steps for sampling and testing of corn and does not include steps for other grains and grain co- products you receive, store, and use as ingredients at your facility."

FDA Issues Warning Letters to Food Importers for Lack of FSVP

FDA issued a number of Warning Letters to food importers for not having FSVP in place for their imported products.  These are for the first two weeks in September, 2022.

Kuzmir Imports Inc., of  Hillburn, New York was not in compliance with the requirements of 21 CFR part 1, subpart L for the following importee foods: mini soup croutons onion garlic from your foreign supplier (b)(4) located in (b)(4); nougat spread from your foreign supplier (b)(4) located in (b)(4); and cashews from your foreign supplier (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kuzmir-imports-inc-633082-08022022

Mexia Pallets LLC of  San Juan, Texas did not develop, maintain, and follow a FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the imported food products, including each of the following food products:
Persian limes imported from (b)(4), located in (b)(4)
Apple soft drink imported from (b)(4), located in (b)(4)
Orange soft drink imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mexia-pallets-llc-633369-08162022

Visvita Corporation of Santa Fe Springs, CA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any foods that the company import, including the following foods:
Visvita Chia Drink - Guanabana Flavour imported from (b)(4), located in (b)(4).
Aloe Vera Drink - Pomegranate Flavor imported from (b)(4), located in (b)(4).
Cold Brew Coffee Powder imported from (b)(4), located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/visvita-corporation-633747-08232022

Mercado Hispano Distributors, pf Tucker, GA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the firm did not develop an FSVP for any of the foods they import, including each of the following:
(b)(4) Cola and (b)(4) Manzana imported from (b)(4), located in (b)(4)
(b)(4) Grapefruit imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mercado-hispano-distributors-llc-634708-08022022

Mina Global Trading Corp, of  Matawan - "As a very small importer, for each food you import, you did not obtain written assurance in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mina-global-trading-corp-636140-08082022

Bharat Ratan LLC. of  Renton, WA id not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically. the company did not develop, maintain, and follow an FSVP for any of the foods imported, including:
Fenugreek leaves, Gur Rewri (Sesame Brittle), and Punjabi Biscuit, imported from (b)(4), located in (b)(4)
Meat Masala (Curry Spice Mix) imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bharat-ratan-llc-634674-08222022

BLUE STONE IMPORT USA INC of Manhasset, NY did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop an FSVP for any of the food products imported, including each of the following foods:
(b)(4) Spicy Chicken Flavor Ramen ((b)(4)) from (b)(4), located in (b)(4)
Wheat Flour from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-stone-import-usa-inc-636668-08032022

Jones Affiliated IncCerritos, CA did not develop an FSVP for any of the foods  imported, including:
Wild Yam Flavor Powder, imported from (b)(4) located in (b)(4)
Premium White Gourd Jam, imported from (b)(4) located in (b)(4)
Red Bean Paste, imported from (b)(4) located in (b)(4)
Black Sesame Powder, imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jones-affiliated-inc-639035-0823202

CT Ice Cream Company Issued A Warning Letter for Lack of Listeria Control

FDA issued a Warning Letter to Royal Ice Cream Company of  Manchester, CT 06040-6534.  FDA 
determined that the RTE ice cream products manufactured by this facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.

FDA state that the company had multiple and repeat findings of L. monocytogenes in the production environment, and thus, the company did not identify and implement preventive controls adequate to ensure that they were significantly minimizing or preventing the hazard of the environmental pathogen L. monocytogenes.  

The company had issued a recall of ice cream after FDA sampling had found positive samples.  This recall was in February, 2022.

"FDA’s inspection included the collection of environmental swabs on January 19, 2022, during production and found that two (2) of seventy-eight (78) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a filler head where RTE ice cream was being dispensed into pint-sized finished packages and one (1) swab was collected from the stainless-steel table where RTE ice cream sandwiches were being prepared. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in three (3) environmental swabs, including two (2) from areas adjacent to food-contact surfaces. Furthermore, in response to our 2022 environmental sample findings and your voluntary recall initiated in February 2022, the Massachusetts Department of Public Health (MDPH) collected retail finished product samples which confirmed L. monocytogenes in one (1) finished product sample of salted caramel ice cream."

These same strains were found to have been present in the facility in past sampling.  "The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen or harborage site in your facility since 2017. We first advised you of the importance of these WGS results on March 4, 2022, and subsequently provided updates to the WGS analysis on the following dates: March 17, 2022, April 7, 2022, and June 30, 2022."

FDA stated that the "hazard analysis did not identify pathogens at your processing step of “(b)(4)” as requiring a preventive control because “Pathogens are unlikely to grow in the low temperature present in the freezer.” However, during the inspection, employees were observed transferring an RTE cookie dough sandwich sheet to the (b)(4), where the ice cream sheet was cut into 4 oz. bars and was exposed to the environment prior to packaging. L. monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE ice cream products, exposed to the environment at steps such as (b)(4), and L. monocytogenes does not require growth to present a hazard."

FDA found a number of issues during inspection that included employees touching non-contact surfaces and then touching food, improper high pressure house use (employees were observed using a high-pressure hose to rinse a stainless-steel pail and to spray the processing room floor, and overspray was aerosolizing immediately adjacent to uncovered flavor vats containing RTE (b)(4), uncovered RTE ingredients on the production table, and near the food-contact surfaces of the filler in the ice cream production area. FDA collected environmental sample (b)(4), swab (b)(4), from head of this filler and detected L. monocytogenes.), 

They had issues with their environmental monitoring system - "did not collect your environmental swabs at the frequency identified within your “Environmental Monitoring Procedures”" and the " environmental monitoring procedure did not identify the locations from which samples will be collected."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-ice-cream-company-inc-630433-07282022
The Royal Ice Cream Company Inc.

MARCS-CMS 630433 — JULY 28, 2022

TX Establishment Recalls Chicken Bowls Labeled as Beef Bowls Creating Allergen Mislabeling

Valley International Cold Storage Acquisition, LLC, a Harlingen, Texas establishment, is recalling approximately 22,061 pounds of frozen beef products due to misbranding and undeclared allergens, the product contains milk, a known allergen, which is not declared on the product label.  The problem was discovered when the producing establishment notified FSIS that it had received consumer complaints that the Korean-Style Beef cartons contained a chicken-based product.

Valley International Cold Storage is a repack facility.  A reminder of the importance of controls for those operations that are repacking product where there may not be visible product to check, but rather a matching of product code to outside packaging.

https://www.fsis.usda.gov/recalls-alerts/valley-international-cold-storage-acquisition-llc-recalls-frozen-beef-products-due
Valley International Cold Storage Acquisition, LLC, Recalls Frozen Beef Products Due To Misbranding And Undeclared Allergens
VICS ACQUISITION, LLC

USDA Issues Health Alert for Chicken Product Due to Undeclared Allergens After Back Label Error

USDA-FSIS is issuing a public health alert due to concerns that the raw, ready-to-cook chicken entrée products may contain egg, a known allergen, which is not declared on the finished product label. "The problem was discovered when the establishment notified FSIS that they received notification from their customer that an incorrect label was on the back of the plastic wrapped metal container. The label on the back of the product contains information related to a chicken cordon bleu product, which does not contain egg. The bacon cheddar chicken product contains egg."

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-chicken-entree-products-due-misbranding-and
FSIS Issues Public Health Alert For Chicken Entree Products Due To Misbranding And An Undeclared Allergen
TAMPA BAY FISHERIES

Expanded Recall for Family Dollar and Their Distribution System - Storing Product Outside of Temperature Requirements

Family Dollar expanded a July 21, 2022 recall for certain FDA regulated products that were stored outside of the required temperature. "This notice covers the recall of Over-the-Counter Medical Devices. An earlier notice issued July 21, 2022 covered a related recall of Over-the-Counter Pharmaceutical Products."

As you may recall, In February of this year, Family Dollar also had a massive recall of products handled by their Arkansas distribution center that had a heavy rat infestation.

Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements
Summary
Company Announcement Date:  August 05, 2022
FDA Publish Date:  September 16, 2022
Product Type:  Medical Devices
Reason for Announcement:  Product was stored outside of labeled temperature requirements.
Company Name:  Family Dollar
Brand Name:  Multiple brand names
Product Description:  Various OTC medical products

Employees Provide Statements on Facility that Produced Frozen Pizza That Was Linked to E. coli Outbreak

This is an interesting read involving an E.coli outbreak in France related to frozen pizza.  The outbreak occurred earlier this year where more than 70 people came down with infections from pathogenic E.coli.  In the article below, employees provided testimonials to how the facility was run.   One could see that food safety was not the primary driver for operating decisions.   

While the cause of the outbreak was not found, the investigation revealed deficiencies in the management of the plant.  This included the "presence of mold, rust and peeling paints was then discovered in the factory, as well as food moths on the production line of Fraîch'Up pizzas."

What employees stated:

"In 2012, Nestlé introduced a new way of managing the site. This is called the Lean method, explains Maryse Tréton of the CGT federation of agri-food. The goal is to minimize all times that are not dedicated to production. We reduce cleaning times and preventive maintenance times to make production as possible."

"Three years later, in 2015, this reduction in cleaning time will be included in a so-called "competitiveness" plan. "Until 2015, the plant operated with 16 hours of production and 8 hours of cleaning per day," say Patrick and Pierre. After 2015, we almost double the production time to 27 hours a day (in three 9-hour shifts) and we almost halve the cleaning time from 8 hours to 4 hours 45.""

"According to them, the consequences of this reorganization are not long in coming: "For us, it meant going faster on cleaning. So, the priority was to clean the production line and the machines. But not what was around, such as the walls and ceilings. It was no longer possible to do everything." Asked about this, the management of Nestlé France confirms that the cleaning time is now less than 5 hours. But it specifies that it has "systematic microbiological samples carried out in different strategic areas of the site"."

"This reduction in cleaning time would have had other consequences. According to the employees whom Radio France's Investigation Unit met, some areas of the factory that were cleaned at least once a year before 2015 would no longer be cleaned. "Before," explains one of them, "we closed the factory for three weeks in August. Meanwhile, the cleaning company that had a contract with the factory could do bottom cleaning. Since then, Nestlé only wants to stop the factory for one week in the summer. So the general condition has deteriorated.""

Some of the outcomes:

• The air conditioning (filtering) system was not cleaned at necessary frequency.
• Flour silos not cleaned for seven years.
• Presence of rodents
• Change of flour to untreated flour where facility had been using pasteurized flour.

What is difficult to tell is to what degree the plant culture, being in France, resisted to more of a US based way of manufacturing.  That is, you can run a lean system provided the necessary procedures are still completed.  Clearly, important activities were not completed and employees had not bought into the lean manufacturing approach.

ICI - France
https://www.francebleu.fr/infos/faits-divers-justice/affaire-buitoni-de-nouveaux-temoignages-accablent-la-direction-1662724306
Buitoni case: new testimonies overwhelm management

Saturday September 10th, 2022 at 6:07 AM - Par Laetitia Cherel, France Bleu, France Bleu Nord

The testimonies of several employees of the Buitoni factory in Caudry shed light on the health deficiencies observed in their factory. They denounce a reduction in cleaning time imposed in 2015 and a change of flour in 2021. Investigation by Laetitia Cherel, investigation unit of Radio France.

Golden Raisins Recalled for Undeclared Sulfites

ANKUR” Muktanand Foods Inc. 483 Thomas Dr. Bensenville, IL 60106 is recalling its 14 Oz (400 gm) packages of “Golden Raisin” because they may contain undeclared sulfites.  The recall was initiated immediately after it was discovered that product was distributed in packaging that did not reveal the presence of Sulfite.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/muktanand-foods-inc-issues-allergy-alert-ankur-brand-golden-raisin-14-oz-400-gm
Muktanand Foods Inc. Issues an Allergy Alert on Ankur Brand Golden Raisin 14 Oz (400 GM)
Summary
Company Announcement Date:  September 08, 2022
FDA Publish Date:  September 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sulfites
Company Name:  Muktanand Foods Inc.
Brand Name:  ANKUR
Product Description:  Golden Raisin

USDA Issues Alert on Mail Order Meal Kits That Have Been Linked to E. coli Outbreak

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that ground beef products in HelloFresh meal kits may be associated with Escherichia coli (E. coli) O157:H7 illness. A recall was not requested because the products are no longer available for purchase.  (The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022).  

This comes as part of an investigation of an outbreak of E. coli O157:H7 and raw ground beef is the probable source of the reported illnesses. Traceback information identified that multiple case-patients received ground beef produced at establishment M46841 and distributed by HelloFresh in meal kits from July 2-21, 2022. Traceback of materials used to produce the ground beef is ongoing and FSIS continues to work with suppliers and public health partners on the investigation.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-specific-ground-beef-hellofresh-meal-kits-due
FSIS Issues Public Health Alert For Specific Ground Beef In HelloFresh Meal Kits Due to Possible E. Coli O157:H7 Contamination

FSIS Announcement

WASHINGTON, Sept. 10, 2022 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that ground beef products in HelloFresh meal kits may be associated with Escherichia coli (E. coli) O157:H7 illness. A recall was not requested because the products are no longer available for purchase.

GA Establishment Recalls Sausage Products After Receiving Complaint for Extraneous Material in the Form of Blue Plastic

Sunset Farm Foods Inc., a Valdosta, Ga. establishment, is recalling approximately 4,480 pounds of chicken and pork smoked sausage products that may be contaminated with extraneous materials, specifically thin blue plastic.  The problem was discovered when the establishment reported to FSIS that it received consumer complaints reporting thin blue plastic embedded inside the pork and chicken sausage product.  There have been no confirmed reports of adverse reactions due to consumption of these products.

https://www.fsis.usda.gov/recalls-alerts/sunset-farm-foods-inc--recalls-sausage-products-due-possible-foreign-matter
Sunset Farm Foods Inc., Recalls Sausage Products Due to Possible Foreign Matter Contamination
SUNSET FARM FOODS, INC.

FSIS Announcement

WASHINGTON, Sept. 7, 2022 – Sunset Farm Foods Inc., a Valdosta, Ga. establishment, is recalling approximately 4,480 pounds of chicken and pork smoked sausage products that may be contaminated with extraneous materials, specifically thin blue plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

TN Establishment Recalls Beef Jerky After 3rd Party Lab Detects Listeria

Magnolia Provision Company, Inc., a Knoxville, Tenn. establishment, is recalling approximately 497 pounds of beef jerky products that may be adulterated with Listeria monocytogenes.  The problem was discovered when the establishment reported to FSIS that it received confirmation from their third-party lab that a product contact surface sample returned as positive for Listeria monocytogenes.


https://www.fsis.usda.gov/recalls-alerts/magnolia-provision-company-inc--recalls-beef-jerky-products-due-possible-listeria
Magnolia Provision Company, Inc., Recalls Beef Jerky Products Due to Possible Listeria Contamination
MAGNOLIA PROVISION COMPANY INC.

OR Grain Processor Recalls Amaranth Grain Due to Potential for Salmonella

Bob's Red Mill Natural Foods, Inc. of   Milwaukie, OR is recalling Organic Amaranth Grain Gluten Free, Organic Amaranth Grain because of the potential to be contaminated with Salmonella.

FDA Enforcement Report

Enforcement Report (fda.gov)
Product Description:
Organic Amaranth Grain Gluten Free, Bob's Red Mill brand, packaged in Standup Pouch (24oz). Each case consists of 4/24 oz. pouches. RETAIL Pouch UPC 0 39978 02910 2. RETAIL Case UPC 10039978029109. Organic Amaranth Grain Gluten Free, Organic Amaranth Grain, packaged in Kraft paper bulk bags (25 lbs). BULK bag UPC 0 39978 10910 1. 

Italian Egg Products Recalled After USDA Finds Eggs Not Eligible for Import

Valrhona Inc., a Brooklyn, New York establishment, is recalling approximately 66 pounds of dried albumin egg products

The products were produced in Italy, a country ineligible to export egg products to the United States.  The problem was discovered when FSIS investigated and determined that the egg products were produced in Italy, a country ineligible to export egg products to the United States.

https://www.fsis.usda.gov/recalls-alerts/valrhona-inc--recalls-ineligible-egg-products-produced-italy
Valrhona Inc. Recalls Ineligible Egg Products Produced In Italy

FSIS Announcement

WASHINGTON, Aug. 31, 2022 – Valrhona Inc., a Brooklyn, New York establishment, is recalling approximately 66 pounds of dried albumin egg products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were produced in Italy, a country ineligible to export egg products to the United States.

Canadian Firm Recalls Frozen RTE Chicken Entrée Products After Testing Finds Listeria

Connoisseur’s Kitchen, a Surrey, British Columbia establishment, is recalling approximately 880 pounds of frozen ready-to-eat (RTE) chicken entrée products that may be adulterated with Listeria monocytogenes.  The problem was discovered when the Canadian Food Inspection Agency notified FSIS that the products are associated with a sample that tested positive for Listeria monocytogenes.

https://www.fsis.usda.gov/recalls-alerts/connoisseurs-kitchen-recalls-imported-frozen-chicken-products-due-possible-listeria
Connoisseur’s Kitchen Recalls Imported Frozen Chicken Products Due to Possible Listeria Contamination

FSIS Announcement

WASHINGTON, Aug. 30, 2022 – Connoisseur’s Kitchen, a Surrey, British Columbia establishment, is recalling approximately 880 pounds of frozen ready-to-eat (RTE) chicken entree products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Smoked Salmon Recalled After WA State Lab Finds Listeria

St. James Smokehouse of Miami, Florida is voluntary recalling 93 cases of St. James Smokehouse brand, Scotch Reserve Scottish Smoked Salmon, 4oz Packages (Product of Scotland) because it has the potential to be contaminated with Listeria monocytogenes.  The recall was the result of a routine sampling by the Washington State Department of Agriculture which revealed that the finished product contained the bacteria.  As of Friday, September 2, 2022 no illnesses have been reported.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/st-james-smokehouse-voluntary-recalls-scotch-reserve-scottish-smoked-salmon-4oz-lot-123172-because
St. James Smokehouse Voluntary Recalls Scotch Reserve Scottish Smoked Salmon 4oz (Lot# 123172) Because Of Possible Health Risk
Summary
Company Announcement Date:  September 02, 2022
FDA Publish Date:  September 02, 2022
Product Type:  Food & Beverages  Fish
Reason for Announcement:  Listeria monocytogenes
Company Name:  St. James Smokehouse
Brand Name:  St. James Smokehouse
Product Description:  Seafood/Fish

Florida Bakery Recalls Animal Crackers for Undeclared Coconut

Plant City, FL August 26, 2022 - Toufayan Bakery is voluntarily recalling Publix GreenWise Animal Crackers due to an undeclared tree nut allergen, specifically coconut  (which we know is not technically a true nut).  Subsequent investigation indicates the problem was caused by a temporary breakdown in the production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/food-co-issues-allergy-alert-undeclared-coconut-product
Food Co. Issues Allergy Alert on Undeclared Coconut in Product
Summary
Company Announcement Date:  August 26, 2022
FDA Publish Date:  September 01, 2022
Product Type:   Food & Beverages
Reason for Announcement:  Undeclared coconut
Company Name:   Toufayan Bakeries
Brand Name:   GreenWise
Product Description:   GreenWise Animal Crackers

Retail Chain Recalls Retail Seafood Meals for Undeclared Allergens

Albertsons Companies today announced it is expanding its July 19, 2022, voluntary recall of ReadyMeals seafood items due to allergens not listed on the ingredient labels. The recall, which is being conducted in continued collaboration with the U.S. Food and Drug Administration, was initiated after an internal technical review identified missing ingredients containing allergens.

Another print-and-apply label issue.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/albertsons-companies-expands-voluntary-recall-select-readymeals-seafood-products-due-undeclared

Albertsons Companies Expands Voluntary Recall of Select ReadyMeals Seafood Products Due to Undeclared Allergens
Summary
Company Announcement Date:  August 31, 2022
FDA Publish Date:  August 31, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared fish allergen
Company Name:  Albertsons Companies
Brand Name:  ReadyMeals
Product Description:  Cooked Shrimp with Cocktail Sauce and Snow Crab Legs Imitation Surimi

Imported Dried Mushrooms Recalled After State Lab Testing Finds Salmonella

Tai Phat Wholesalers, LLC of Capitol Heights, MD is recalling 4 types of packages of its “Three Coins Dried Mushrooms” because they have the potential to be contaminated with Salmonella.  No illnesses have been reported to date in connection with this problem.  The potential for contamination was noted after routine testing by Maryland Department of Health of items bought at a retail store which revealed the presence of Salmonella in some packages of "Three Coins Dried Mushrooms".

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tai-phat-wholesalers-llc-recalls-three-coins-dried-mushrooms-because-possible-health-risk
Tai Phat Wholesalers, LLC Recalls “Three Coins Dried Mushrooms” Because of Possible Health Risk
Summary
Company Announcement Date:  August 29, 2022
FDA Publish Date:  August 30, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  Tai Phat Wholesalers, LLC
Brand Name:  Three Golden Coins
Product Description:  Dried whole or sliced mushrooms

PA Dairy Recalls Cheeses After FDA Finds Listeria in Samples

Keswick Creamery of Newburg, Pa is recalling Calverley Cheese, Vulkwin’s Folly Cheese, Vermeer Cheese, Havarti Cheese, Wallaby Cheese, Cider Washed Tomme Cheese, Feta Cheese, Whole Milk Ricotta, Bovre Cheese (plain, oregano and garlic, herbes de provence, cranberry and honey) and Quark Cheese (plain, dill and onion), because it has the potential to be contaminated with Listeria monocytogenes.  Product was distributed to regional farmers' markets and farm store retail sites..

The recall was the result of a routine sampling program conducted by the FDA which revealed some finished products contained the bacteria. Keswick Creamery has ceased the production and distribution of all products as FDA and the company continue their investigation as to what caused the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/keswick-creamery-carrock-farm-llc-recalls-cheese-because-possible-health-risk
Keswick Creamery at Carrock Farm, LLC Recalls Cheese Because of Possible Health Risk
Summary
Company Announcement Date:  August 29, 2022
FDA Publish Date:  August 29, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Keswick Creamery
Brand Name:  Keswick Creamery
Product Description:  Various cheeses

Salad Dressing Recalled for Allergens After Wrong Back Label Used

Van Law Food Products Inc. is recalling Whole Foods Market 365 Organic Creamy Caesar Dressing because it contains undeclared Soy and Wheat allergens.  The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of Soy and Wheat allergen. Subsequent investigation indicates that the problem was caused when the back label from another product was mistakenly put on the product being recalled.

We have seen a good number of this type of labeling issue resulting in a recall.  While the front label has the product name in large letters, the back label with the nutritional and allergen informaiton has the name in smaller type, thus making it easy to mess up.  This labeling activity (matching the front and back label against product in the bottle) needs to be an Allergen Preventive Control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/van-law-food-products-issues-allergy-alert-undeclared-soy-and-wheat-product
Van Law Food Products Issues Allergy Alert on Undeclared Soy and Wheat in Product
Summary
Company Announcement Date:  August 26, 2022
FDA Publish Date:  August 26, 2022
Product Type: Food & Beverages
Reason for Announcement:  Undeclared Soy and Wheat
Company Name:  Van Law Food Products Inc.
Brand Name:  Whole Foods Market 365
Product Description:  Organic Creamy Caesar Dressing