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

USDA Issues Health Alert for Chicken Nugget Product for Potential Bone Fragments

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen, fully cooked Wegmans breaded chicken breast nuggets that may be contaminated with extraneous material, specifically bone fragments. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.  The product was produced on August 26, 2024.  FSIS was notified of the issue after Wegmans received multiple consumer complaints of bone fragments in the frozen fully cooked breaded chicken breast nugget product.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-wegmans-frozen-fully-cooked-chicken-nuggets-due
FSIS Issues Public Health Alert for Wegmans Frozen Fully Cooked Chicken Nuggets Due to Possible Extraneous Material Contamination

Perdue Foods LLC

FSIS Announcement

WASHINGTON, Jan. 27, 2025 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen, fully cooked Wegmans breaded chicken breast nuggets that may be contaminated with extraneous material, specifically bone fragments. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.

California Firm Recalls Bread Crumbs for Undeclared Sesame

La Fiesta Food Products, LLC, La Mirada, CA is recalling 8 oz packages of La Fiesta brand Unseasoned Bread Crumbs (Pan Rayado) and Seasoned Bread Crumbs (Pan Rayado Sazonado). The products contain sesame as an undeclared allergen. Additionally, the labels do not include the allergen declaration in Spanish.  The recall was initiated after discovering that the product contained undeclared sesame. Further investigation revealed that the issue was caused by errors on the product labeling.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-la-fiesta-brand-bread-crumbs-unseasoned-and-seasoned-undeclared-sesame
Recall of La Fiesta Brand Bread Crumbs (Unseasoned and Seasoned) for Undeclared Sesame
Summary
Company Announcement Date:  January 25, 2025
FDA Publish Date:  January 28, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen (sesame)
Company Name:  La Fiesta Food Products, LLC.
Brand Name:  La Fiesta
Product Description: Breadcrumbs (pan Rayado)

CA Firm Expands Recall for Corn Puff Snack with Undeclared Milk Allergen

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is expanding its January 17, 2025 recall of 2.46 oz packages of Shirakiku brand Curvee Puffs Corn Puff Snack Curry Flavor. The expansion now includes two additional flavors; Sea Salt & Umami Flavor and Corn Potage Flavor. The product contains  undeclared milk.

The FDA Recall Notice was obviously not well reviewed prior to its issuance.  See the struck-out sections below where these were obviously not associated with this product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wismettac-asian-foods-issues-allergy-alert-undeclared-milk-curvee-puffs-corn-puff-snack
Wismettac Asian Foods Issues Allergy Alert on Undeclared Milk in Curvee Puffs Corn Puff Snack
Summary
Company Announcement Date:  January 28, 2025
FDA Publish Date:  January 28, 2025
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared milk.
Company Name:  Wismettac Asian Foods, Inc.
Brand Name:  Shirakiku
Product Description:  Snack foods-Corn Puffs

Company Announcement

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is expanding its January 17, 2025 recall of 2.46 oz packages of Shirakiku brand Curvee Puffs Corn Puff Snack Curry Flavor. The expansion now includes two additional flavors; Sea Salt & Umami Flavor and Corn Potage Flavor. The product contains the undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume those products.

The product was distributed nationwide in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI through retail stores, restaurants, online business. The product was also exported to Mexico and Peru.

The product is packaged in a 2.46 oz flexible bag. The UPC for the product is located on the back right side of the product package. This issue affected all lot codes or date codes.

The contamination was discovered after samples were collected from a store in Baltimore, Maryland and subsequent analysis by State of Maryland Department of Health Laboratories Administration revealed the presence of Listeria Monocytogenes in some 200g packages of Daily Veggies Enoki Mushroom form Korea. Remaining products in the warehouse had been destroyed.

Consumers who have purchased 200g packages of Daily Veggies Enoki Mushroom from October to November of 2024 are urged to destroy the products immediately or return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-808-1018.

Consumers who have purchased Dynacare Baby Powder (see products/lots below) should discontinue use immediately and return it for a full refund.

Item Number  Item Description  Packing Size  UPC Code
#78512  SNACK CURVEE PUFF CURRY SK  20/ 2.46 OZ  074410785123 #65155
SNACK CURVEE PUFFS SEA SALT & UMAMI SK
20/ 2.46 OZ
074410651558
#65156
SNACK CURVEE PUFFS CORN POTAGE SK
20/ 2.46 OZ
074410651565

No illnesses have been reported to date in connection with this issue.




The recall was initiated after discovering that the product contained an undeclared allergen (milk). The last distribution of the product in the marketplace was on January 10, 2025.




Consumers who have purchased the product are urged to return them to the place of purchase for a full refund.




Consumers with questions may contact the company at recall@wismettacusa.com.

NY Wholesaler Recalls Herb Powder Due to Elevated Lead Levels

New York Wholesale Group of Hicksville, NY is recalling Zaarah Herbals Shatavari Powder, to the consumer/user level because it has the potential to be contaminated with elevated levels of lead. The recall is the result of an analysis conducted by Connecticut Department of Consumer Protection; Food & Standards Division that revealed the product contained elevated levels of lead.

How did the lead get into the product?  To make an educated guess, the powder is derived from the plant root, so the lead would probably have been taken up from the soil / growth medium.

What is Shatavari powder?  I asked AI and this is what I got.

Shatavari is a herb that is a member of the asparagus family. It is also known as Asparagus racemosus and is a natural adaptogen, which means it helps the body cope with physical and emotional stress. Shatavari is considered a general health tonic to improve vitality and is a staple in ayurvedic medicine. Shatavari powder is a fine powder made from the dried roots of the shatavari plant and is commonly used in traditional Ayurvedic medicine to support the female reproductive system and promote overall health and wellness

So an important question is, will shatavari powder make one's urine smell similar to when one eats asparagus.  Well, according to a journal article, Asparagus racemosus (Shatavari) does contain Asparagusic acid, the compound responsible for the asparagus-related pee odor, but this does not seem to be thing (of note).

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/new-york-wholesale-group-recalls-zaarah-herbals-shatavari-powder-because-possible-health-risk
New York Wholesale Group Recalls Zaarah Herbals Shatavari Powder Because of Possible Health Risk
Summary
Company Announcement Date:  January 27, 2025
FDA Publish Date:  January 27, 2025
Product Type:  Food & Beverages  Contaminants
Reason for Announcement:  Product may be contaminated with elevated levels of lead.
Company Name:  New York Wholesale Group
Brand Name:   Zaarah Herbals
Product Description:  Shatavari Powder

WI Firm Recalls Bacon Seasoning Due to Undeclared Soy, A Result of a Supplier Substitution

TS Food Packaging, a Wisconsin firm, is recalling its “Rural King” and “Wabash Valley Farms” Bacon Seasoning due to the presence of an undeclared soy ingredient.  The recall was initiated after it was discovered via a manufacturing quality verification that the soy containing ingredient was a substitute provided by a supplier without notification of the presence of Soy. Subsequent investigation indicated the problem was caused by a substitution review process gap between the supplier and their customer base, corrective actions are in place to prevent recurrence.

There are two issues here.  One, the supplier made a substitution without notifying the customer, the receiving company, that a substituted product contained soy.   However, while this is a supplier oversight, the receiving company must have processes to prevent such issues.  For one, the purchasing department should have been on top of this.  I find it difficult to think that the supplier did not notify them of the need for a substitution.  With that, the purchasing department would then notify quality department of the need for a review. Second, the receiving company, (AKA, the customer), was not reviewing incoming ingredients close enough to detect the issue.  A simple product and label check of the incoming item would have caught this.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ts-food-packaging-recalling-its-rural-king-and-wabash-valley-farms-bacon-seasoning-due-presence
TS Food Packaging is Recalling its “Rural King” and “Wabash Valley Farms” Bacon Seasoning Due to the Presence of an Undeclared Soy Ingredient
Summary
Company Announcement Date:  January 24, 2025
FDA Publish Date:  January 24, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen – soy
Company Name:  TS FOOD PACKAGING
Brand Name:  Wabash Valley Farms, Rural King
Product Description:  Bacon flavor popcorn seasoning

KY Establishment Recalls Chicken Product for Undeclared Allergens

Custom Food Solutions, a Louisville, Kentucky establishment, is recalling approximately 105,164 pounds of ready-to-eat (RTE) frozen drunken chicken product due to misbranding and undeclared allergens, the product may contain egg and sesame, known allergens, which are not declared on the product label.  FSIS discovered the problem during routine labeling review activities, when it found that the egg and sesame ingredients were not listed on the final product label.

https://www.fsis.usda.gov/recalls-alerts/custom-food-solutions-recalls-ready-eat-frozen-drunken-chicken-product-due
Custom Food Solutions Recalls Ready-To-Eat Frozen Drunken Chicken Product Due to Misbranding and Undeclared Allergens

WASHINGTON, Jan. 22, 2025 – Custom Food Solutions, a Louisville, Kentucky establishment, is recalling approximately 105,164 pounds of ready-to-eat (RTE) frozen drunken chicken product due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product may contain egg and sesame, known allergens, which are not declared on the product label.

NY Firm Recalls Raisons with High Level of Undeclared Sulfites

Apna Wholesale Inc of Hicksville, NY, is recalling its 7oz and 14oz “Paras Premium Golden Raisins” because they contain undeclared Sulphur Dioxide (sulfites).   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 the presence of sulfites in “Paras Premium Golden Raisins” which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the “Paras Premium Golden Raisins” revealed they contained 56.8 milligrams per serving.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apna-wholesale-issues-alert-undeclared-sulfites-paras-premium-golden-raisins
Apna Wholesale Issues Alert on Undeclared Sulfites in “Paras Premium Golden Raisins
Summary
Company Announcement Date:  January 07, 2025
FDA Publish Date:  January 22, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sulfites
Company Name:  Apna Wholesale Inc
Brand Name:  Paras
Product Description:  Premium Golden Raisins

NY Firm Recalls Imported Chocolate Chip Cookies for Undeclared Almonds

D. COLUCCIO & SONS, of  Brooklyn, NY, is recalling its 300 gram packages of “Colussi Cantuccini Chocolate Drops” chocolate chip cookies because they may contain undeclared almonds.  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 through a recall foreign recall notice from product manufacturer in Italy. Subsequent investigation indicated the problem was caused by temporary breakdown in the company’s production and packaging processes.

According to the company website, "D. Coluccio and Sons, Inc. is a family owned and operated Italian specialty food importer and retailer located in the heart of Bensonhurst, Brooklyn"  In this case, this importer would be under the FSVP which requires the importer to verify the supplier is operating under PCHF and with that, controlling hazards with preventive controls.  In this case, the foreign supplier would need to have allergen preventive controls because they are handling allergens other than what is going into this produce.  This is where the utilization of Appendix 1 for process / facility related hazards (as summarized in FSCPA's form 231) is a must.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/d-coluccio-sons-issues-allergy-alert-undeclared-almonds-colussi-cantuccini-chocolate-drops-cookies
D. Coluccio & Sons, Issues Allergy Alert on Undeclared Almonds in “Colussi Cantuccini Chocolate Drops” Cookies
Summary
Company Announcement Date:  January 21, 2025
FDA Publish Date:  January 21, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almond
Company Name:  D. Coluccio & Sons
Brand Name:  Colussi
Product Description:  “Colussi Cantuccini Chocolate Drops” chocolate chip cookies