Gerber Recalls Biscuit Product After Flour Supplier Issues Recall for Foreign Material

Gerber Products Company is initiating a voluntary recall of limited batches of Gerber® Arrowroot Biscuits out of an abundance of caution due to the potential presence of soft plastic and/or paper pieces that should not be consumed. The material comes from an arrowroot flour supplier who initiated a recall. We are no longer working with the flour supplier.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gerber-products-company-announces-voluntary-recall-limited-batches-arrowroot-biscuits-out-abundance
Gerber Products Company Announces Voluntary Recall of Limited Batches of Arrowroot Biscuits Out of an Abundance of Caution Due to Potential Presence of Foreign Material Following Supplier Recall
Summary
Company Announcement Date:  January 26, 2026
FDA Publish Date:  January 28, 2026
Product Type:  Food & Beverages
Reason for Announcement:  potential presence of soft plastic and/or paper pieces
Company Name: Gerber Products Company
Brand Name: Gerber
Product Description:  Arrowroot biscuits

FDA Issues Warning Letter to a Small California Pita Baking Company for GMP Violations

FDA issued a Warning Letter to Middle East Baking Co. a pita and bagel manufacturing facility located in Burlingame, CA .

The biggest issue was excessive insect activity, primary beetles, which were found throughout the facility.  There was also some rodent poop.  Along with this, as one would expect, was a lack of cleaning was also sited.  This resulting excessive food material buildup is what the beetles are feeding on.  There were some other GMP issues.  Surprisingly, not much mention of the post-processing area where post-process contamination seems like it could be a huge Salmonella risk.

Also of note,  this "facility meets the definition of a “qualified facility” under 21 CFR § 117.3; therefore, therefore not subject to having a food safety plan, and only "subject to the modified requirements in 21 CFR § 117.201 of the CGMP & PC rule.".

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/middle-eastsolis-baking-company-inc-dba-middle-east-baking-co-708017-07252025
Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co.
MARCS-CMS 708017 — July 25, 2025

Food Companies Push Back on Texas Law Requiring Warning Label for Certain Ingredients

Food companies are suing the State of Texas after the state's new law requiring warning labels for over 40 different ingredients.  "Section 9 of the law requires food manufacturers to include warning labels on products that include 44 listed ingredients, including artificial additives, dyes and chemicals, informing customers that governments in Australia, Canada, the European Union, or the United Kingdom have labeled the ingredients as “not recommended for human consumption.”"  Note, this is not based upon what the US has determined, but what other countries have determined.

From the Texas Rule

Sec. 431.0815.  FOOD CONTAINING ARTIFICIAL COLOR, ADDITIVES, OR CERTAIN BANNED CHEMICALS. (a) A food manufacturer shall ensure each food product the manufacturer offers for sale in this state includes a warning label disclosing the use of any of the following ingredients, if the United States Food and Drug Administration requires the ingredient to be named on a food label and the ingredient is used in a product intended for human consumption:

The warning label must:  (1)  include the following statement if the food contains an ingredient listed in Subsection (a), printed in a font size not smaller than the smallest font used to disclose other consumer information required by the United States Food and Drug Administration:

“WARNING: This product contains an ingredient that is not recommended for human consumption by the  appropriate authority in Australia, Canada, the European Union, or the United Kingdom.";

Many of these ingredients have been long used in the US and are in many of the foods we eat....well, foods I eat....you know, those highly processed foods like potato chips and snack cakes.

Here are some from the list which I knew to be readily used.

(Entire list - https://legiscan.com/TX/text/SB25/id/3247967  about half way down the webpage)

• Bleached flour is treated white flour treated creating a softer texture that absorbs more liquid, making it great for delicate cakes, cookies, and pie crusts
• BHA and BHT - synthetic antioxidants used as preservatives in foods (cereals, chips, meats, etc) to prevent fats and oils from going rancid
• Diacetyl occurs naturally and it gives butter its characteristic taste. Because of this, manufacturers of artificial butter flavoring, margarines or similar oil-based products typically add diacetyl to give that characteristic aroma/flavor.
• Potassium aluminum sulfate is a firming agent for pickles, leavening in baking, pH control
• Sodium aluminum sulfate is used in baking powder as a slow-acting leavening agent
• Sodium Lauryl Sulfate is an emulsifier/thickener in some dried eggs, marshmallows, and beverage bases
• Stearyl tartrate is an emulsifier and dough strengthener to improve dough texture
• Stearyl tartrate acts as a dough strengthener, emulsifier, and stabilizer in foods, improving consistency

To heck with the sugar in that pack of Ho-Hos, it is the dough conditioner you have to worry about.

Reuters
https://www.reuters.com/legal/government/food-industry-groups-sue-texas-over-ingredient-warning-labels-2025-12-08/
Food industry groups sue Texas over ingredient warning labels
By Dietrich Knauth

December 8, 20251:54 PM ESTUpdated December 8, 2025

NY Distributor Recalls Bangladeshi Indian Snack Mix After State Lab Detects Undeclared Peanuts

South Asian Food Inc. of Maspeth, Queens, NY is recalling its 12.34oz (350gm) packages of Bengal King Jhal Chanachur food treats because they may contain undeclared peanuts.   The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed that the peanut-containing product was distributed in packages that did not reveal the presence of peanuts.

The recalled Bengal King Jhal Chanachur were distributed nationwide in retail stores and through mail orders. 

"Chanachur or Bombay mix is a Bangladeshi Indian snack mix (namkeen) which consists of a variable mixture of spicy dried ingredients, such as fried lentils, peanuts, chickpea flour ghatia (sev), corn, vegetable oil, chickpeas, flaked rice, fried onion and curry leaves. This is all flavored with salt and a blend of spices that may include coriander and mustard seed." (Ref)


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/south-asian-food-inc-issues-allergy-alert-undeclared-peanuts-bengal-king-jhal-chanachur
South Asian Food Inc. Issues Allergy Alert on Undeclared Peanuts in "Bengal King Jhal Chanachur "
Summary
Company Announcement Date:  December 12, 2025
FDA Publish Date:  December 12, 2025
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared peanut allergen
Company Name:  South Asian Food Inc
Brand Name:  Bengal King
Product Description:  Jhal Chanachur food treats

FDA Issues Warning Letter To California Baker for Lack of Sanitation Controls

FDA issued a Warning Letter to Marin Baking LLC, a manufacturer of ready-to-eat (RTE) bread products, located in San Rafael, CA.  There were a number of issues including:

• Allergen preventive controls did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded 
• Sanitation procedures were not completely followed, including not following schedule cleaning procedures.  
• Did not have adequate sanitation verification procedures.
• Did not have adequate controls in place for allergen cross-contact, as evidenced by observations involving sesame seeds. 
• The facility’s written hazard analysis did not consider recontamination with environmental pathogens, such as Salmonella, at all steps where  RTE bread products are exposed to the environment. 
• There were issues with rodents and insects.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/marin-baking-llc-700600-05282025
WARNING LETTER

Marin Baking LLC
MARCS-CMS 700600 — May 28, 2025
Recipient:
Farid M. Radwan, Co-owner
Michael D. Humphrey, Co-owner
Marin Baking LLC
1512 4th Street
San Rafael, CA 94901
United States

FDA Issues Warning Letter to Maryland Facility for Lack of Food Safety Plan

FDA issued a Warning letter to One Roof LLC of Baltimore, MD after FDA inspected the ready-to-eat (RTE) food manufacturing facility on October 24, 2024, through December 9, 2024. This inspection was initiated as a follow-up to the voluntary recall of Atwater’s Spider Web Tarts on October 21, 2024, due to undeclared almond in the product.   FDA stated that the "Spider Web Tarts 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 become contaminated with filth or may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule."

Basically, the facility did not have a food safety plan for any of the products they produced, and with that, did not have established controls for hazards including allergens.   What controls were in place were not followed per the company's procedures.  The Warning Letter is lengthy covering various aspects that the company should be following.  There are also misbranding violations.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/one-roof-llc-701988-05202025
One Roof LLC
MARCS-CMS 701988 — May 20, 2025

Kentucky Distributor Recalls Over 100 Items After Inspectors Find Significant Rat Infestation

On May 27, 2025, Pan-African Food Distributors of Louisville, Kentucky initiated a recall of over 100 food and health care / cosmetic products after an inspection found a rat infestation in the facility.  "FDA continues to have concerns for all products held and distributed by Pan-African Food Distributors due to the insanitary conditions observed at the facility during a routine FDA inspection, including a rodent infestation and numerous rodent droppings on multiple product containers."

"A May 2025 FDA inspection of the firm’s distribution center in Louisville, Kentucky revealed the presence of an active rodent infestation and numerous rodent droppings on multiple product containers. The state of Kentucky has mandated the firm halt operations due to the absence of a required permit and has implemented a blanket quarantine of product. The state is urging the voluntary disposal of all contaminated food and will prohibit the business from reopening until the infestation is completely addressed. FDA has recommended Pan-African Food Distributors recall all products of concern currently on the market, and the firm has agreed. FDA is issuing this public health alert to notify the customers and consumers about the public health risk that these products pose."

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-consumers-retailers-and-distributors-not-use-eat-sell-or-serve-products-pan-african-food

FDA Advises Consumers, Retailers, and Distributors Not to Use, Eat, Sell, or Serve Products from Pan-African Food Distributors Inc. dba East Africa Boutique LLC
Products were held under insanitary conditions with potential contamination with filth.

Product:  
Potentially contaminated products include cosmetic products, various ready-to-eat and/or shelf stable food items including infant nutritional cereals, baking ingredients, and other food products imported and distributed by Pan-African Food Distributors Inc. doing business as (dba) East Africa Boutique LLC. Products may or may not include a label with the firm name.

Ohio Firm Recalls Croissants for Not Specifically Stating Wheat in Regard to Flour Ingredient

Element 112, LLC dba Madeline’s Pâtisserie of Sylvania, Ohio is issuing a voluntary recall of a specific batch of our ready-to-eat croissants, due to a labeling error. The ingredient statement on the exterior of the box was labeled as “flour” and does not accurately reflect the contained allergen of “wheat” 

Product distribution was limited to Ohio and Michigan.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/element-112-llc-dba-madelines-patisserie-issues-allergy-alert-undeclared-wheat-croissants-and
Element 112, LLC dba Madeline’s Pâtisserie Issues Allergy Alert on Undeclared Wheat in Croissants and Croissant Buns
Summary
Company Announcement Date:  May 15, 2025
FDA Publish Date:  May 20, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen - wheat.
Company Name:  Element 112, LLC dba Madeline’s Pâtisserie
Brand Name:  Madeline’s Pâtisserie
Product Description:  Croissants and Croissant Buns

NY Importer Recalls Imported Soybean Paste for Undeclared Wheat

May Flower International Inc of Maspeth, NY, is recalling its 8.82-ounce/250g packages of “Beijing Soybean Paste” food treats because they may contain undeclared wheat.   This recall was initiated after the United States Food and Drug Administration discovered during a routine inspection that the product declared flour as an ingredient, but wheat (an allergen) was undeclared.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/may-flower-international-inc-issue-allergy-alert-undeclared-wheat-beijing-soybean-paste
May Flower International Inc., Issue Allergy Alert on Undeclared Wheat in “Beijing Soybean Paste”
Summary
Company Announcement Date: April 11, 2025
FDA Publish Date:  April 17, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  May Flower Internation, Inc.
Brand Name:  May Flower International
Product Description:  Soybean Paste

In Memoriam - Dr. Steven Goodfellow

Dr. Steve Goodfellow passed away this past week at the age of 83. He was an incredible food microbiologist, having a huge impact on the industry. He was also a remarkable person with a huge presence.

His work in the area of applied microbiology has been truly impactful. His research achievements include the development of USDA Appendix A and B as well as contribution to the development of cooking temperatures established in the Food Code and the Nut Processing Guidelines.  His work was always on the leading edge such as exploring the increased heat resistance of Salmonella in low water activity products such as flour. I worked for Steve nearly 30 years ago, and his understanding at that time on topics such as Listeria survival and control in food processing plants or E. coli contamination of beef continues to be remarkably pertinent today.

As a highly valued consultant, most of his work is only known to those companies and employees who needed his help. Think Winston Wolf in Pulp Fiction....rolls in, lays out the plan to solve the problem, and then executes that plan. During my time with him, it was a continuous flow of company sponsored research projects, troubleshooting, and training. Whether it was identifying and eliminating the source of Listeria in various plants to prevent those plants from being shut down, conducting research on TPP carcass washes, or working with companies developing new products, he was the ultimate fixer.

As for his character Steve was one of a kind, truly a force of nature. I'd say a mixture of Johnny Cash, Humphrey Bogart (cool factor) and Jack Nicholson (edgy). He was outspoken, direct to the point, and never backed down, especially when he knew he was right which he usually was. He was a wonderful boss and mentor. I have continued to draw upon all that I learned from him.

 

(Early 1990s IFT Annual Conference, Steve and I with Bill Brown in the background)

FDA Warning Letter to UT Bakery Highlights Preventive Control and GMP Misses Typical for Bakery

FDA issued a Warning Letter to Salt City Baking Company of Murray, Utah,  a baking company that produces ready-to-eat (RTE) bread products.  In the Preventive Controls for Human Foods training, these topics are covered, including the need to address controls associated with exposed RTE foods.

First the company "did not conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE bread products."

• Did not consider environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it required a preventive control. [The] facility manufactures RTE bread products (such as White Cottage sliced bread) which are exposed to the environment after baking and handled by employees prior to packaging. 
• In addition, when contamination with environmental pathogens is a hazard requiring a preventive control, [one] must verify the effectiveness of this preventive control by performing environmental monitoring for an environmental pathogen or for an appropriate indicator organism, by collecting and testing environmental samples (see 21 CFR 117.165(a)(3)). [The company is] not performing environmental monitoring to evaluate the effectiveness of  sanitation practices regarding employee practices and cleanliness of food-contact surfaces.
• Did not consider mycotoxins as a known or reasonably foreseeable hazard to determine whether it required a preventive control. [The] bread products (such as White Cottage sliced bread) contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard.
• A facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410).
• The written allergen preventive controls do not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded 
• The written Preventive Controls document indicates that the hazard of allergen cross-contact will be significantly minimized or prevented through scheduling and segregation practices. However, the allergen preventive control procedures do not cover sesame, nor do they include preventive control management components (monitoring, verification, and corrective action) for any allergens (see 21 CFR 117.140).
• In addition, the bread products are packaged in plastic bags and then the bags are placed into a cardboard case for distribution for use by foodservice establishments. The finished product labels are applied to the outside of the cardboard case. We note that you did not have adequate controls in place for undeclared allergens regarding monitoring and verification activities.

GMP Issues

Michigan Bakery Cited by FDA for Issues with Food Safety Plan and Its Implementation

FDA issued a Warning Letter to Knickerbocker 365 Inc, a processor of ready-to-eat (RTE) breads, rolls, and buns manufacturing facility located in Madison Heights, MI.

This points out many of the same issues identified in bakery operations.

The hazard analysis did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control.  

• The company did not consider recontamination with environmental pathogens, such as Salmonella, at steps where your RTE breads, rolls, and buns are exposed to the environment. The RTE breads, rolls, and buns are exposed to the environment at post-baking steps (including “Cooling,” “De-panning,” “Slicing,” and “Packaging”) where they could be contaminated with environmental pathogens such as Salmonella, and do not receive a lethal treatment or otherwise include a control measure (such as formulation lethal to the pathogen) that would significantly minimize pathogens.
• The RTE breads, rolls, and buns come into direct contact with post-baking equipment, such as the “(b)(4) slicer” “the (b)(4) Slicer,” and the “(b)(4) Slicer.” However, The FDA noted that written sanitation procedures, documented on the “(b)(4) Cleaning Checklist,” for equipment used post-baking do not indicate sanitizer concentration or how to clean utensils and clean out-of-place (COP) equipment (e.g., pieces of equipment (i.e., blades) from the (b)(4) slicing machine) that are cleaned and sanitized in the (b)(4) sink.
• In addition, the  facility’s environmental testing document is not clear on the frequency of collecting environmental samples for pathogens, including Salmonella. In the “Purpose” section, the document states that “Testing is to occur at the (b)(4) procedures at (b)(4).” However, in the “Background” section, the document indicates that (b)(4) for “Salmonella sp.” will be “collected quarterly.” The “Limit and Testing occurrences” in the “Procedures” section notes testing for Salmonella “at least annually.” Furthermore, the procedure does not indicate the analytical method that will be used.
• The company did not identify and implement a supply-chain preventive control to ensure control of ingredient-related pathogens.The hazard analysis for RTE breads, rolls, and buns, “21.0 HACCP Last Revision 3/2024,” identified at receiving steps for wheat flour, whey (b)(4), egg, and walnut ingredients, pathogens as a hazard associated with these ingredients used in your RTE products. The hazard analysis further identified a supply-chain control to control the pathogen hazard. However, The company did not have a written supply-chain program covering the pathogen hazard in the referenced ingredient.
• The written allergen preventive control did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use, and for food labeling to ensure the food is not misbranded

The food safety plan was not prepared, nor was its preparation overseen, by one or more preventive controls qualified individual(s), as required by 21 CFR 117.126(a)(2). The hazard analysis indicates that it was approved by the President/Owner (Sandra Sokana) who is not a PCQI, and there is no PCQI trained individuals or individuals who are qualified through experience to develop and apply a food safety system.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/knickerbocker-365-inc-687624-09302024
WARNING LETTER
Knickerbocker 365 Inc.
MARCS-CMS 687624 — September 30, 2024

FDA Cites Bakery for Preventive Control and GMP Issues

FDA issued a Warning Letter to Mena Food Group, Fort Lauderdale, FL, after inspecting the facility which manufactures ready-to eat (RTE) bakery products including breads, cakes, and pastries.   The issues seen here are things that have been previously cited with other bakery operations, as well as other operations producing RTE foods.

Environmental pathogens considered a hazard requiring a preventive controls - The facility did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The RTE bakery products are exposed to the environment at post-baking steps at the (b)(4) steps where they can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes. The packaged bakery products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard

Environmental monitoring is required - In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Your facility is not monitoring the environment for an environmental pathogen, or for an appropriate indicator organism, to verify the effectiveness of your sanitation controls.

Need to consider mycotoxins as a hazard in the hazard analysis - The facility did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures RTE bakery products (e.g., breads) containing high protein wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, mycotoxins are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). This program was not in place.

Allergen labeling is required - The facility’s written hazard analysis considered undeclared allergens; however, the company determined this to be the responsibility of the customer and the consumer. The  facility manufactures finished products that contain allergens such as wheat, milk, egg, soy (soybean lecithin), coconut, walnuts, and sesame. They are distributed to restaurants, hotels, nursing homes, hospitals, and distributors/wholesalers with labeling that does not include an ingredient statement and allergen declaration.  Examples - the challah burger buns, challah knot rolls, and sesame challah burger buns were staged for distribution in the staging area. They were packaged in pre-printed plastic bags without the wheat, soy, and sesame allergens declared.  The 12-inch hoagie rolls were staged for distribution in the staging area. They were packaged in clear plastic bags that did not declare wheat and soy allergens.

Allergen controls for cleaning to prevent cross contact - Allergen controls procedures for nuts do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Specifically, the hazard analysis for various RTE breads, cakes, and pastries identified the hazard of allergen cross-contact at the (b)(4) steps. At these steps, they use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day.

The written allergen preventive control procedure states that “(b)(4)”. However, this procedure was not followed. On October 30, 2023, the rotating round turntable and utensils used by the  employee were not cleaned after handling the RTE pina colada cake (containing wheat, soy, eggs, milk and coconut) and before handling the RTE mocha cake (containing wheat, soy, eggs, and milk but not coconut).

GMP Issues

• A pastry area employee walked outside the firm to her car wearing her hairnet and plastic work apron. She returned to the pastry area without washing her hands or replacing her hairnet and plastic apron.
• A cake room employee wearing a hairnet, gloves, and plastic apron was observed preparing raw chocolate cigars. He exited the cake room door leading to the outside. A few moments later he returned through the same exterior door wearing a hairnet, gloves, apron, and the facemask. He immediately returned to preparing raw chocolate cigars without washing his hands and changing his hairnet, gloves, and plastic apron.
• A bearded pastry area employee mixing RTE frosting/icing was using his gloved hand to transfer the frosting to another bowl. While he was transferring the frosting, part of his bare arm/arm hair came in direct contact with the frosting. Also, this employee was wearing a beard cover; however, it was pulled down under his chin during the transferring of the frosting.
• In your pastry room and cake room, employees did not wash their hands or gloves after touching their face.
• Open beverage bottles were observed 1) In the bread processing area, under the preparation tables, while the employees were manipulating raw dough; 2) In the pastry area, under preparation tables, while the employees were manipulating in-process products; 3) Inside the pastry area reach-in freezer, where ingredients, in-process, and finished products are stored.
• In the cake room, your facility has a black multi-drawer toolbox where utensils (e.g., spatulas, knives, cake cutting wire) are stored after they are cleaned. These utensils are taken from the toolbox and immediately used to decorate and cut RTE cake room products. The toolbox contained personal items such as glasses, keys, and opened beverage bottles.
• The plant was not maintained  in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). Specifically: a. the fluorescent light located directly above the processing tables appeared to have a black mold-like substance on the light diffusers. Adjacent ceiling tiles were also observed with an apparent similar substance, and b. On  two large fans in the cutting and packing room were observed to have excessive filth and debris on the metal wire fan guard.  The fans were observed blowing onto RTE uncovered cupcakes on a pan rack cart.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mena-food-group-llc-673814-08082024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024

Maryland Firm Recalls Tarts Due to Undeclared Almond

Atwater’s of Baltimore, MD, is recalling its clam shell packages of spider web tarts sold 10/19/24 and 10/20/24 because they contain undeclared almond flour.   The recall was initiated after it was discovered that the almond containing product was distributed in packaging that did not reveal the presence of almonds, see below for photos of both the product and packaging in question. Subsequent investigation indicated the problem was caused by a temporary breakdown in the company’s production and labeling processes.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/atwaters-issues-allergy-alert-undeclared-tree-nuts-spider-web-tart
Atwater’s Issues Allergy Alert on Undeclared Tree Nuts in “Spider Web Tart”
Summary
Company Announcement Date:  October 28, 2024
FDA Publish Date:  October 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergens
Company Name:  One Roof, LLC.
Brand Name:  Atwater’s
Product Description:  Tarts

CA Noodle Company Received FDA Warning Letter for Failure to identify Hazards and Implement Controls

FDA issues a Warning Letter to Alfred Louie Inc, a sprouting operation and noodle manufacturing facility, located in Bakersfield, CA.  The items noted in the Letter include:

• Did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured,
• Did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control.  The company processes products containing different allergen profiles on the same equipment (e.g., bowl mixer, noodle sheet maker, sheet rollers, former/cutter, and finished product conveyor) and using shared utensils on the same production day.
• Did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The company manufactures Pan Fry Fresh Noodles and Deep Fry Fresh Noodles products, which contain wheat flour as an ingredient. Wheat flour has been associated with mycotoxins such as deoxynivalenol (DON)
• Did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Product is manufactured with processing equipment (e.g., (b)(4) noodle cutters) with metal-to-metal contact. The company does not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.
• Misbranding the finished product labels fail to accurately declare major food allergens, as required by section 403(w)(1) of the Act. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alfred-louie-inc-680624-09112024
Alfred Louie, Inc.
MARCS-CMS 680624 — September 11, 2024

Florida Distributor Recalls Corn Pancakes for Undeclared Wheat

TIPICAL LATIN FOOD CORP of Miami, FL is recalling Cachapa de Maiz sweet corn pancakes labeled under Los Andes Foods, because it may contain undeclared wheat.  The recall was initiated after it was discovered that product containing wheat was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by a labeling issue during the company's labeling process. 

On the label, flour is listed (in addition to corn flour).  The label should have identified this as wheat flour. The label was improperly designed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tipical-latin-food-corp-issues-allergy-alert-undeclared-wheat-cachapa-de-maiz
Tipical Latin Food, Corp. Issues Allergy Alert on Undeclared Wheat in Cachapa de Maiz
Summary
Company Announcement Date:  October 11, 2024
FDA Publish Date:  October 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Wheat
Company Name:  Tipical Latin Food Corp.
Brand Name:  Los Andes Foods
Product Description:  Cachapa de Maiz sweet corn pancakes

Lancaster Country (PA) Bakery Issued Warning Letter

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507.  McClure's is a self-described Amish bakery.  (Located in the heart of Amish Country, McClures Bakery has been bringing delicious Amish baked goods to our customers for more than 50 years. The bakers at our family-owned and operated bakery specialize in making shoofly pies, cakes, bread, and other traditional recipes using the finest ingredients.)

• Did not have a hazard analysis completed for all products.
• Did not identify Salmonella as a hazard requiring a preventive control.
• Did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) as a known or reasonably foreseeable hazard
• did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control
• Duct tape is not a sanitary fix - Investigator observed production of Country Maid Creme Filled Doughnuts with Lot Code: 263 and noted duct tape at the joints of the grey PVC pipe which appeared uncleanable and was located directly above exposed creme inside the doughnut filler-hopper.
• Added allergen to Contains statement although not used in formulation - "labeling is false or misleading because “peanut” is declared in the “Contains” statements; however, “peanut” is not an ingredient in the formulations of these products. You stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to the CGMP and PC rule. Instead, firms must comply with the applicable CGMP and PC requirements to address allergen cross-contact."
• A number of labeling-related issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcclures-lancaster-old-fashioned-llc-670611-05162024
McClure’s Lancaster Old Fashioned, LLC
MARCS-CMS 670611 — MAY 16, 2024

Recipient:
Mr. Thomas Keenan
Owner & President
McClure’s Lancaster Old Fashioned, LLC
1212 Reading Road
Bowmansville, PA 17507
United States

Use of Almond Flour in Pie Instead of Wheat Flour Results in Allergic Reaction

New Seasons Market of Portland, Oregon is recalling Strawberry Rhubarb Bakewell Tart, because it contains undeclared almond. "After a staff member consumed the Strawberry Rhubarb Bakewell Tart and had a mild reaction but did not seek medical attention, the manufacturer of the product was notified of this potential allergic reaction. The manufacturer confirmed the product did contain almond flour, but almond was not listed in the product specification. New Seasons Market initiated this recall because the scale label does not declare almond."

So this appears to be a mis-formulation issue where almond flour was inadvertently used.  Also could be cross-contact where residual almond flour was not properly removed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/new-seasons-market-issues-allergy-alert-undeclared-almonds-strawberry-rhubarb-bakewell-tart
New Seasons Market Issues Allergy Alert on Undeclared Almonds in Strawberry Rhubarb Bakewell Tart
Summary
Company Announcement Date:  June 04, 2024
FDA Publish Date:  June 04, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almonds
Company Name:  New Seasons Market
Brand Name:  New Seasons Market
Product Description:  Strawberry Rhubarb Bakewell Tart

Warning Letter to Cookie Dough Processor Highlights FDA's Attention to Allergens and Supplier Controls

In this Warning Letter issued to a cookie dough manufacturing company, it is important to see the approach FDA is taking with regard to allergens and supplier-controlled hazards.

 Cookies-n-Milk, LLC, a processor of ready-to-eat (RTE) cookie dough located in McKinney, TX received an inspection.  The inspection was in response to using incorrect packaging, which resulted in undeclared peanut allergen in the product, as containers of Chocolate Chip Edible Cookie Dough which do not declare the allergen peanuts were filled with Peanut Butter Edible Cookie Dough which contain peanuts.  Basically, the company put peanut butter dough into chocolate chip dough containers.

First on the lack of allergen preventive controls at the labeling step.  As part of the hazard analysis, the company did not identify and determine that undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard that requires a preventive control at the packaging/labeling step.  With that, the company did not monitor or verify that these preprinted labels are applied to the correct product during production (such as at the packaging/labeling step). The firm’s own investigation indicated that a lack of packaging controls resulted in containers of “Chocolate Chip Edible Cookie Dough,” which do not declare the allergen peanuts on the product label, being filled with Peanut Butter Edible Cookie Dough which contain peanuts

The next issue noted, and an item seen in recent Warning Letters, was the company did not identify and evaluate mycotoxins  in the incoming peanut butter as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The "facility manufactures RTE edible cookie dough products containing peanut butter, which has been associated with mycotoxins such as aflatoxin. A knowledgeable person manufacturing/ processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in peanut butter and peanut butter-containing ingredients.  With not identifying mycotoxins as a hazard requiring a preventive control, the company did not conduct supplier verification activities for mycotoxins in peanut butter and peanut butter-containing ingredients.

FDA then cited the lack of supporting documentation for corrective action as written in the company's  response to the inspection  In a response letter, the company indicated that the "dough hazard analysis will be revised to identify undeclared allergens due to mislabeling/packaging as a potential hazard with controls at packaging implemented with monitoring and verification procedures defined” and “The Edible Cookie Dough hazard analysis will be revised to identify Mycotoxins as a potential hazard for Wheat Flour and Peanut Butter with controls at the supplier level implemented with monitoring and verification procedures defined.” FDA responded, "However, the response did not contain sufficient supporting documentation for FDA to adequately evaluate your corrective actions. In addition, the response did not include a complete updated hazard analysis (to identify mycotoxins as a hazard requiring a preventive control for peanut butter and peanut butter-containing ingredients, and to identify undeclared allergens as a hazard requiring a preventive control at the packaging/labeling step) or revised food safety procedures."

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cookies-n-milk-llc-672621-04222024
Cookies-n-Milk, LLC
MARCS-CMS 672621 — APRIL 22, 2024

FDA Cites Detroit Tortilla Baker for Inadequate Controls

FDA issued a Warning Letter to Hacienda Mexican Foods, a Detroit MI processor of ready-to-eat (RTE) soft wheat flour tortilla products.  Like so many Warning Letters recently issued, the hazard analysis  did not properly identify or evaluate all known or reasonably foreseeable hazards.  

The company "did not identify and evaluate recontamination with environmental pathogens, such as Salmonella, to determine whether it is a hazard requiring a preventive control in [the] RTE soft flour tortillas, as required by 21 CFR 117.130(a)(1). Specifically, [the] firm’s written hazard analysis did not consider the hazard of recontamination with environmental pathogens at the “(b)(4)” and “(b)(4) steps."

With that, there were inadequate sanitation controls in the post-processing environment.

Also, FDA felt that mycotoxins in incoming flour was not addressed as well as survival of pathogens in baking.

The last item is interesting.  FDA states "your food safety plan does not include written baking procedures or established parameters for baking time and/or temperature. Your firm’s Food Safety Assistant informed our investigators that your firm does not have a documented established critical limit for baking time and temperature or any validation for the adequacy of the baking process."

It did not help the firm with this statement, "you do not have controls in place to address the hazard of survival of bacterial pathogens such as Salmonella and E. coli in the baking process. While our investigators observed production of RTE soft flour tortillas, they noted that the digital temperature display for the oven did not appear to be functioning. Your firm management confirmed that it was not functioning, and it could not provide a temperature readout. Your firm’s Production Manager indicated that the digital temperature display has not functioned at any point while he had worked at your firm, which is approximately 20 years."

Finally, there are issues with the allergen preventive controls as well as a host of GMP violations.


Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hacienda-mexican-foods-llc-663221-04042024
Hacienda Mexican Foods, LLC
MARCS-CMS 663221 — APRIL 04, 2024