Michigan Firm Recalls No Bake Cookies After Computer Error Causes Formulation Mistake and Adds Undeclared Peanuts

Wesco, Inc. of Muskegon, MI is recalling 750 units of Wesco Mint No Bake Cookie Bites, because it may contain undeclared peanut.  The recall was initiated after it was discovered that Wesco Mint No Bake Cookie Bites containing peanut butter were distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by incorrect product formulation within the manufacturing facility’s new software system.

Validating software - when new software is installed, it must be thoroughly validated.  Validation should continue through the start of use in production.

Verifying formulations - the strength of a HACCP based system is having double checks in place to ensure product safety.  In this case, a manual check is there to ensure the proper formulation is in place, specifically addressing allergens.  The allergens within the formulation must match what is on the package.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wesco-inc-issues-voluntary-recall-and-allergy-alert-undeclared-peanut-wesco-mint-no-bake-cookie
Wesco, Inc. Issues Voluntary Recall and Allergy Alert on Undeclared Peanut in Wesco Mint No Bake Cookie Bites
Summary
Company Announcement Date:  March 08, 2024
FDA Publish Date:  March 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Peanut Allergen
Company Name:  Wesco, Inc.
Brand Name:  Wesco Fresh
Product Description:  Mint No Bake Cookies
Company Announcement
Wesco, Inc. of Muskegon, MI is recalling 750 units of Wesco Mint No Bake Cookie Bites, because it may contain undeclared peanut. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Unfortunate Disconnect Between Supplier and Retailer Leads to Death Due to Undeclared Peanuts

Tragic stories bring home the importance of preventing simple errors such as getting proper labels on packages.  In a most recent case, a 25 year old world-class dancer "tragically lost her life due to anaphylactic shock resulting from a severe allergic reaction to a cookie manufactured by Cookies United and sold by the supermarket chain Stew Leonard's. The FDA and Stew Leonard's issued a recall of the Vanilla Florentine Cookies that were sold at Stew Leonard's in Danbury and Newington, CT from November 6 – December 31, 2023.  The cookie contained peanuts which were not listed as part of the ingredients."

Unfortunately for Steward Leonards, they were made aware of the inclusion of peanuts earlier in the year, but failed to update their label.  From Cookies United Press Release "Stew Leonard’s claimed in an earlier press release that “The cookies contain peanuts, which was an ingredient not disclosed to Stew Leonard’s by the manufacturer.” [bold is ours]  Unfortunately, considering the tragedy of these circumstances, we need to point out that Stew Leonard’s was notified by Cookies United in July of 2023 that this product now contains peanuts and all products shipped to them have been labeled accordingly.  This product is sold under the Stew Leonard’s brand and repackaged at their facilities.  The incorrect label was created by, and applied to, their product by Stew Leonard’s."

A very unfortunate disconnect between the supplier and the retailer.

Ohio Firm Recalls Cookie Bites for Undeclared Allergens

Eban’s Bakehouse is recalling all of its Sweet Indulgences cookie bites, packaged in 12-count, 11.85 oz boxes, due to undeclared milk and soy allergens. The labeling issue was discovered during a routine inspection conducted by the Ohio Department of Agriculture. There have been no reports of illness involving the products addressed in this recall.

The issue is that ingredients were not investigated and associated allergens identified.  For example, butter is listed, but the allergen milk was not identified.  The soy coming with the soy lecithin used in chocolate.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ebans-bakehouse-issues-voluntary-recall-due-undeclared-milk-and-soy-allergens
Eban’s Bakehouse Issues a Voluntary Recall Due to Undeclared Milk and Soy Allergens
Summary
Company Announcement Date:  December 16, 2023
FDA Publish Date:  December 16, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk and soy
Company Name:  Eban’s Bakehouse
Brand Name:  Eban’s Bakehouse
Product Description:  Cookie Bites

Quaker Oats Recalls Granola Products Due to Potential Salmonella Contamination

The Quaker Oats Company today announced the recall of specific granola bars and granola cereals listed below because they have the potential to be contaminated with Salmonella.  
The products listed below are sold throughout the 50 United States, Puerto Rico, Guam and Saipan.
To date, Quaker has received no confirmed reports of illness related to the products covered by this recall.

While the company did not specifically state the reason for the recall, outside the fact that there were no reported illnesses, this would lead one to believe that it was perhaps a positive test result.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/quaker-recalls-granola-bars-and-granola-cereals-due-possible-health-risk
Quaker Recalls Granola Bars and Granola Cereals Due to Possible Health Risk
Summary
Company Announcement Date:  December 15, 2023
FDA Publish Date:  December 15, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential for Salmonella contamination
Company Name:  The Quaker Oats Company
Brand Name:  Quaker
Product Description:  Granola Bars and Granola Cereals

Gift Baskets Recalled for Undeclared Nut Allergens After Discovery of Incorrect Labeling of Hazelnut Cookies

Wine Country Gift Baskets is taking precautionary measures of voluntarily recalling all gift baskets produced with Acorn Baking Company raspberry crème filled cookies. During production, it was discovered that some packages of the raspberry crème filled cookies contained hazelnut crème filled cookies. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-food-recall-raspberry-creme-filled-cookie
Urgent Food Recall— Raspberry Crème Filled Cookie
Summary
Company Announcement Date:  November 24, 2023
FDA Publish Date:  November 24, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Hazelnuts
Company Name:  Wine Country Gift Baskets
Brand Name:  Acorn Baking Company
Product Description:  Raspberry crème filled cookies

TX Firm Recalls Edible Cookie Dough Product After Packaging Issue Results in Undeclared Peanut

Cookies-N-Milk, of McKinney, TX is recalling their 6oz cups of "Chocolate Chip Edible Cookie Dough" because it may contain undeclared peanuts.  After receiving a notification from a distributor, the investigation indicates the problem occurred at the packaging stage.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cookies-n-milk-issues-allergy-alert-undeclared-peanuts-chocolate-chip-edible-cookie-dough
Cookies-N-Milk Issues Allergy Alert on Undeclared Peanuts in Chocolate Chip Edible Cookie Dough
Summary
Company Announcement Date:  October 04, 2023
FDA Publish Date:  October 04, 2023
Product Type:  Food & Beverages  Bakery Product/Mix  
Reason for Announcement:  Undeclared Peanuts
Company Name:  Cookies-N-Milk
Brand Name:  Cookies-N-Milk
Product Description:  Chocolate Chip Cookie Dough

Chocolate Cookie Dough Recalled for Foreign Material - Wood Fragments

Nestlé USA is initiating a voluntary recall of a limited quantity of NESTLÉ® TOLL HOUSE® Chocolate Chip Cookie Dough “break and bake” Bar (16.5 oz) products due to the potential presence of wood fragments.  Nestle stated that they "are confident that this is an isolated issue and we have taken action to address."  

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-nestler-toll-houser-chocolate-chip-cookie
Nestlé USA Announces Voluntary Recall of Limited Quantity of NESTLÉ® TOLL HOUSE® Chocolate Chip Cookie Dough Bar (16.5 Oz) Due to Potential Presence of Foreign Material
Summary
Company Announcement Date:  August 10, 2023
FDA Publish Date:  August 11, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of wood fragments
Company Name:  Nestle USA
Brand Name:  NESTLÉ® TOLL HOUSE®
Product Description:  Chocolate Chip Cookie Dough

Company Announcement

ARLINGTON, VA., August 10, 2023 — Nestlé USA is initiating a voluntary recall of a limited quantity of NESTLÉ® TOLL HOUSE® Chocolate Chip Cookie Dough “break and bake” Bar (16.5 oz) products due to the potential presence of wood fragments.

Lunch Kits Recalled After Supplied Ingredient Was Subject to Cross Contact with Allergen

"The USDA FSIS is issuing a public health alert for Never Any! brand ready-to-eat (RTE) ham and cheese lunch kits containing chocolate chip cookies that may contain peanut, a known allergen, which is not declared on the finished product label. A recall was not requested because the products are believed to no longer be available for purchase.  The problem was discovered when the producing establishment was notified by their chocolate chip cookie supplier that the chocolate chip cookies may contain peanut residue, a known allergen, which is not declared on the label. "  The product was made in Canada by Maple Leaf Foods and was distributed by Aldi retail chain. 

This is an issue which is getting more attention - an ingredient supplier's allergen control program. In this case, the supplier of the chocolate chip cookie item allowed allergen cross contact with peanuts. While this is a USDA product, the FDA covers this as part of the Preventive Control regulation under Supply Chain Preventive Control.  In the upcoming update to the FSPCA training curriculum that covers this regulation, there will be added attention to this issue.

 

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-never-any-brand-ready-eat-ham-and-cheese-lunch-kits
FSIS Issues Public Health Alert for Never Any! Brand Ready-To-Eat Ham and Cheese Lunch Kits Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, July 19, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for Never Any! brand ready-to-eat (RTE) ham and cheese lunch kits containing chocolate chip cookies that may contain peanut, a known allergen, which is not declared on the finished product label. FSIS is issuing this public health alert to ensure that consumers with an allergy to peanut are aware that this product should not be consumed. A recall was not requested because the products are believed to no longer be available for purchase.

NY Boutique Ice Cream Company Recalls Product Due to Undeclared Walnuts

Van Leeuwen Ice Cream of Brooklyn, NY is voluntarily recalling 4,096 frozen 14 oz pints of its French Ice Cream product "Brown Sugar Chunk” because it contains an undeclared allergen, walnuts.  The recall was voluntarily initiated after a customer complaint led to the discovery that the ice cream in this lot contains walnuts but was distributed in packaging that did not declare the presence of walnuts. The cause of the product labeling error is being investigated.

This appears to be an issue of the product filled into prelabeled cups.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/van-leeuwen-issues-voluntary-recall-undeclared-walnuts-its-brown-sugar-chunk-ice-cream-pints
Van Leeuwen Issues Voluntary Recall on Undeclared Walnuts in its Brown Sugar Chunk Ice Cream Pints
Summary
Company Announcement Date:  May 23, 2023
FDA Publish Date:  May 23, 2023
Product Type:  Food & Beverages  Ice Cream/Frozen Dairy
Reason for Announcement:  Undeclared walnuts
Company Name:  Van Leeuwen Ice Cream LLC
Brand Name:  Van Leeuwen
Product Description:  BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FRENCH ICE CREAM

CDC Investigating Salmonella Outbreak Associated with Cookie Dough

FDA and CDC, in collaboration with state and local partners, are investigating an outbreak of Salmonella Enteritidis infections linked to Chocolate Chip Cookie and S’mores Bars dough sold at Papa Murphy’s franchises. To date, there have been 18 cases with 2 hospitalizations.

Papa Murphy's is a Washington based take-and-bake food company that operates over 1,300 outlets, primarily in the US. The company's primary focus is pizza, where you have the raw pizza prepared, and then you take it home to bake it. They also sell raw cookie dough, and provide cooking instructions.

This is just another reminder for the significant risk of Salmonella in raw cookie dough.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-raw-cookie-dough-may-2023
Outbreak Investigation of Salmonella: Raw Cookie Dough (May 2023)
Do not eat, sell, or serve Papa Murphy’s Chocolate Chip Cookie and S’mores Bars dough. FDA’s investigation is ongoing.
Current Update
May 23, 2023
Case Counts
Total Illnesses: 18
Hospitalizations: 2
Deaths: 0
Last Illness Onset: May 2, 2023
States with Cases: CA, ID, MO, OR, WA, UT
Product Distribution: Nationwide

The FDA and CDC, in collaboration with state and local partners, are investigating an outbreak of Salmonella Enteritidis infections linked to Chocolate Chip Cookie and S’mores Bars dough sold at Papa Murphy’s franchises.

Fudge Cookies Recalled Due to Undeclared Peanut Allergen Due to Supplier Issue

B&G Foods announced today it is voluntarily recalling three cases (18 individual boxes) of a single date code of 6.4 oz. Back to Nature Fudge Mint Cookies, with a “best by” date of OCT 02 2023, after being notified that an ingredient supplied by a third-party ingredient supplier was contaminated with peanut, an allergen not declared on the cookie box label. 

Another supplier-related issue...perhaps the same supplier involved in the recent hot chocolate recalls?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bg-foods-issues-voluntary-allergy-alert-undeclared-peanut-three-cases-back-naturer-fudge-mint
B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies
Summary
Company Announcement Date:  February 01, 2023
FDA Publish Date:  February 01, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  B & G Foods, Inc.
Brand Name:  Back to Nature
Product Description:  Fudge Mint Cookies
Company Announcement  

Another Recall for Undeclared Peanut Allergens in Peanut Butter Hot Chocolate

Two Rivers Coffee of South Plainfield, NJ is voluntarily recalling its peanut butter single serve hot chocolate pods distributed as "Brooklyn Bean Peanut Butter Cup Hot Cocoa", "Pingo Peanut Butter Cookie Hot Chocolate" and “Cold Stone Peanut Butter Cup Perfection” in 12 count, 40count, and 100 count boxes produced from January 2021 to November 2022, due to an undeclared peanut allergen in an ingredient from Two Rivers Coffee’s raw material supplier that was not disclosed to Two Rivers Coffee or its licensors.

This may be the same supplier that had peanut allergen issues that resulted in a similar recall last month.  (Jan 2023).  

It is always a good idea to track recalls and to investigate issues in your own facility when there are recalls related to what you do.

Two Rivers Coffee Issues Allergy Alert on Undeclared Peanut Allergen in Peanut Butter Hot Chocolate
Summary
Company Announcement Date:  January 30, 2023
FDA Publish Date:  January 31, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Two Rivers Coffee
Brand Name:  Brooklyn Bean
Product Description:  3 Flavors of Peanut Butter and/or Hot Cocoa Pods

FDA Issue Warning Letter to FL Ice Cream Company, Source of July 2022 Listeria Outbreak

FDA issued a Warning Letter to Big Olaf Creamery, an operation that was responsible for a July 2022 Listeria outbreak with 28 cases ("Among 28 ill people with available information, 27 (96%) were hospitalized, and seven illnesses were in pregnant people or their newborns. One death and one fetal loss attributable to listeriosis have been reported.")

In short summary, the company did not have a food safety plan in place, and along with that, apparently no controls for potential hazards.  The company had not identified Listeria as a concern, and testing was only completed after it was the determined that the company as the source of the Listeria outbreak.  

"After the product recall and in response to FDACS’s positive L. monocytogenes environmental and finished product samples and FDACS’s stop sale order ceasing all sale of ice cream products, your firm contracted with a third-party laboratory to conduct environmental swabbing (b)(4). Multiple pieces of equipment used to manufacture RTE ice cream products were reported positive for L. monocytogenes by your contract laboratory, including (b)(4). Additionally, four swabs of finished product ice cream buckets ((b)(4)) were reported positive for L. monocytogenes."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/big-olaf-creamery-llc-dba-big-olaf-642758-12092022
Big Olaf Creamery LLC dba Big Olaf
MARCS-CMS 642758 — DECEMBER 09, 2022

Edible Cookie Dough Recalled for Foreign Material - Soft Plastic Film

Nestlé USA is initiating a voluntary recall of a limited quantity of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® due to the potential presence of soft plastic film.  This voluntary recall is isolated to three batches of Edible Chocolate Chip Cookie Dough tubs from NESTLÉ® TOLL HOUSE® that were produced August 1-3, 2022. These products were distributed to retailers nationwide.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-limited-quantity-edible-chocolate-chip-cookie-dough-tubs
Nestlé USA Announces Voluntary Recall of Limited Quantity of Edible Chocolate Chip Cookie Dough Tubs from NESTLÉ® TOLL HOUSE® Due to Potential Presence of Foreign Material
Summary

Company Announcement Date: November 03, 2022
FDA Publish Date: November 03, 2022
Product Type: Food & Beverages
Reason for Announcement: Potential for Soft Plastic Film
Company Name: Nestle USA
Brand Name: NESTLÉ® TOLL HOUSE®
Product Description: Edible Chocolate Chip Cookie Dough

CA Firm Recalls Cookies for Undeclared Almonds and Hazelnuts

Daiso California LLC of La Mirada, CA is recalling its Tiramisu Twist Cookies (sku 4562138450820) because the product contains almonds and hazelnuts, ingredients that are not identified on the packaging.   The recall was initiated after it was discovered that the Tiramisu Twist Cookie packaging did not adequately disclose the presence of the nuts. Sale of the product has been suspended, and Daiso California has pulled the product from store shelves.  There has been one reported case of allergic reaction to this product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-tiramisu-twist-cookies-almonds-and-hazelnuts-not-identified-ingredients
Daiso Issues Allergy Alert on Tiramisu Twist Cookies Almonds and Hazelnuts Not Identified as Ingredients on Packaging
Summary
Company Announcement Date:  October 27, 2022
FDA Publish Date:  October 28, 2022
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Undeclared almonds and hazelnuts
Company Name:  Daiso California LLC
Brand Name:  Daiso
Product Description:  Tiramisu Twist Cookies

CO Candy Company Recalls Salted Caramel Cookie Product After Incorrect Packaging of Peanut Containing Cookies

Hammond’s Candies of Denver, CO is recalling 5-ounce boxes of Hammond’s Salted Caramel Cookies, because they may contain undeclared peanuts. The recall was initiated after a routine product check revealed that peanut-containing product had been packed and distributed in incorrect packaging, which did not declare the presence of peanuts. Further investigation has determined the root cause to be a temporary failure of the manufacturer’s packing and product release process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hammonds-candies-issues-allergy-alert-undeclared-peanut-salted-caramel-cookies
Hammond’s Candies Issues Allergy Alert on Undeclared Peanut in Salted Caramel Cookies
Summary
Company Announcement Date:  October 17, 2022
FDA Publish Date:  October 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Peanuts
Company Name:  Hammond’s Candies
Brand Name:  Hammond’s
 Product Description:  Salted Caramel Cookies

Nestle Recalls Stuffed Chocolate Chip Cookie Dough After Complaints Involving Small White Plastic

Nestlé USA is initiating a voluntary recall of ready-to-bake refrigerated NESTLÉ® TOLL HOUSE® STUFFED Chocolate Chip Cookie Dough with Fudge Filling products due to the potential presence of white plastic pieces.  The company took the recall action out of an abundance of caution after a small number of consumers contacted Nestlé USA about this issue.  This voluntary recall is isolated to NESTLÉ® TOLL HOUSE® STUFFED Chocolate Chip Cookie Dough with Fudge Filling products that were produced between June and September 2022. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-nestler-toll-houser-stuffed-chocolate-chip-cookie-dough-fudge
Nestlé USA Announces Voluntary Recall of NESTLÉ® TOLL HOUSE® STUFFED Chocolate Chip Cookie Dough with Fudge Filling Products Due to Potential Presence of Foreign Material
Summary
Company Announcement Date:  October 13, 2022
FDA Publish Date:  October 17, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Foreign Object
Company Name:  Nestle USA
Brand Name:  NESTLÉ® TOLL HOUSE®
Product Description:  STUFFED Chocolate Chip Cookie Dough with Fudge Filling

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

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.

Cookies in a Bear Shaped Container Recalled After Metal Wire Found in Cookie

D. F. Stauffer Biscuit Co., Inc. is voluntarily recalling 44 oz Market Pantry White Fudge Animal Cookies because they may contain metal. The product comes in a clear plastic jug formed to a bear shape.  The recall was initiated when metal (wire) was found inside a portion of the cookies. Foodborne foreign objects that are hard, sharp, and large are more likely to cause serious injury or dental injury. Foodborne foreign objects that are flexible, not sharp, and smaller in length are more likely to cause minor injuries such as transient choking or small lacerations in the gastrointestinal system.




https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/df-stauffer-biscuit-co-inc-issues-voluntary-recall-market-pantry-white-fudge-animal-cookies-best
D.F. Stauffer Biscuit Co., Inc. Issues a Voluntary Recall on Market Pantry White Fudge Animal Cookies with a Best By Date of 21FEB2023 Due to Possible Foreign Object Contamination
Summary
Company Announcement Date:  August 24, 2022
FDA Publish Date:  August 25, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Foodborne Foreign Object
Company Name:  D. F. Stauffer Biscuit Co.
Brand Name:  Market Pantry
Product Description:  White Fudge Animal Cookies