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

Maryland Firm Recalls Various Products Made with Recalled Cucumbers

TGD Cuts, LLC of Jessup, MD has initiated a voluntary recall of the specific tub and tray items listed below because they contained cucumber from Bedner Growers Inc., which had the potential to be contaminated with Salmonella.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tgd-cuts-llc-initiated-voluntary-recall-cucumber-bedner-growers-inc-which-had-potential-be
Tgd Cuts, LLC Initiated Voluntary Recall of Cucumber from Bedner Growers Inc., Which Had the Potential to Be Contaminated with Salmonella
Summary
Company Announcement Date:  June 04, 2025
FDA Publish Date:  June 04, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  TGD Cuts, LLC.
Brand Name:  Multiple brands
Product Description:  Fresh cucumbers and salsa and salads containing fresh cucumbers

Virginia Firm Recalls Organic Crackers for Undeclared Sesame Due to Wrong Label Application

Firehook of Virginia is recalling one lot of Firehook brand Classic Sea Salt Organic Crackers because they may contain undeclared sesame.  The recall was initiated on 5/30/2025 after it was discovered that the sesame-containing product was distributed in packaging that did not reveal the presence of sesame. Subsequent investigation indicates that the problem was caused by a temporary breakdown in the company’s production and packaging processes causing the wrong labels to be applied to the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/firehook-virginia-issues-allergy-alert-undeclared-sesame-classic-sea-salt-crackers
Firehook of Virginia Issues Allergy Alert on Undeclared Sesame in Classic Sea Salt Crackers
Summary
Company Announcement Date:  June 04, 2025
FDA Publish Date:  June 04, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Sesame
Company Name:  Firehook of Virginia
Brand Name:  Firehook
Product Description:  Crackers

NJ Firm Recalls Churro Bites for Undeclared Milk

Camerican International of Paramus, NJ is recalling 7.05 oz boxes of Aldi Brand Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream because they may contain undeclared milk.  The recall was initiated after a consumer discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes that has subsequently been corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camerican-international-inc-issues-allergy-alert-undeclared-milk-aldi-brand-casa-mamita-churro-bites
Camerican International, Inc. Issues Allergy Alert on Undeclared Milk in Aldi Brand Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream
Summary
Company Announcement Date:  June 03, 2025
FDA Publish Date:  June 03, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  Camerican International
Brand Name:  Aldi brand Casa Mamita
Product Description:  Churro Bites

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.

Illinois Establishment Recalls Tallow Products After Determination that Products Repackaging Done Without Federal Inspection

Sulu Organics LLC, a Bartlett, Ill. establishment, is recalling approximately 6,166 pounds of pork lard and beef tallow products that were produced without the benefit of federal inspection.  These items were shipped to retail locations nationwide and do not bear the USDA mark of inspection.

The problem was discovered when FSIS received consumer complaints that the pork lard and beef tallow products for sale online did not bear the mark of inspection. FSIS personnel determined the establishment purchased pork lard and bulk beef tallow from an FSIS regulated facility and produced product into smaller retail size containers that were relabeled without the benefit of FSIS inspection

https://www.fsis.usda.gov/recalls-alerts/sulu-organics-llc-recalls-pork-lard-beef-tallow-products-produced-without-benefit
Sulu Organics LLC Recalls Pork Lard & Beef Tallow Products Produced Without Benefit of Inspection

WASHINGTON, June 3, 2025 - Sulu Organics LLC, a Bartlett, Ill. establishment, is recalling approximately 6,166 pounds of pork lard and beef tallow products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

USDA Issues Health Alert for Ground Meat Products from VT Establishment That May Contain Pathogenic E. coli

The USDA-FSIS is issuing a public health alert for ground beef products produced by NPC Processing Inc. of Shelburne, VT that may be contaminated with E. coli O157:H7. A recall was not requested because the products are no longer available for purchase.  The problem was discovered when the establishment notified FSIS that they shipped into commerce ground beef product that tested positive for E. coli O157:H7.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ground-beef-products-due-possible-e--coli-o157h7-1
FSIS Issues Public Health Alert for Ground Beef Products Due to Possible E. Coli O157:H7 Contamination

WASHINGTON, June 3, 2025 - The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert for ground beef products that may be contaminated with E. coli O157:H7. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

Utah Establishment Recalls Jerky and Snack Sticks Due to Undeclared Anchovies Associated with the Worcestershire Sauce

Springville Meat & Cold Storage Co., Inc., Springville, Utah establishment, is recalling approximately 15,388 pounds of heat-treated shelf-stable ready-to-eat (RTE) beef jerky/beef snack stick products and voluntarily inspected elk, venison and buffalo jerky products due to misbranding and undeclared allergens.  The product contains fish (anchovies), a known allergen, which is not declared on the product label.  The problem was discovered during production observations by FSIS inspectors, revealing that the Worcestershire sauce used in jerky and snack stick products contained anchovies. The establishment previously used Worcestershire sauce without anchovies, but it was discovered that the new Worcestershire sauce does contain anchovies.

This is a very common issue when using Worcestershire sauce.  The company uses one without anchovies for which the labels are designed, but then somewhere along the line, someone buys the other (and better) Worcestershire sauce with anchovies but doesn't change the label.

https://www.fsis.usda.gov/recalls-alerts/springville-meat-cold-storage-co--inc--recalls-beef-jerky-beef-snack-stick-products
Springville Meat & Cold Storage Co., Inc., Recalls Beef Jerky/ Beef Snack Stick Products and Voluntarily Inspected Elk, Venison and Buffalo Jerky Products Due to Misbranding and Undeclared Allergens

FDA Warning Letter to Processor of RTE Smoothie Mix Highlights Common Food Safety Plan Issues

FDA issued a Warning Letter to a Charlotte NC company that manufactures blender bombs....a mixture of ingredients that are put into the blender with juices or other liquid.  This is a RTE product because there will be no lethal step provided by the consumer.

This Warning Letter highlights additional issues that are important when writing and implementing the plan.  

The company did not consider pathogens as a hazard in this RTE product.

"The hazard analysis contained in your Food Safety Plan for Cold Pressed (Unbaked Products), dated October 17, 2022 (“food safety plan”), did not consider vegetative bacterial pathogens as a known or reasonably foreseeable hazard for coffee, hemp seeds, and chia seeds to determine whether they require a preventive control. You contract manufacture RTE “Java Jolt Blender Bombs” containing these ingredients, which have been associated with vegetative bacterial pathogens (such as Salmonella spp.). These ingredients do not receive a lethal treatment in your facility."

The hazard analysis contained in your Food Safety Plan for Cold Pressed (Unbaked Products), dated October 17, 2022 (“food safety plan”), did not consider vegetative bacterial pathogens as a known or reasonably foreseeable hazard for coffee, hemp seeds, and chia seeds to determine whether they require a preventive control. You contract manufacture RTE “Java Jolt Blender Bombs” containing these ingredients, which have been associated with vegetative bacterial pathogens (such as Salmonella spp.). These ingredients do not receive a lethal treatment in your facility.

The metal detector was identified as a preventive control, but was not operated as though it was a preventive control.  What is more interesting is that the response to FDA  was not adequate.  It is important when responding that one not only shows it was fixed, but provide proof the fix actually works.

"We reviewed your response, including the video you sent showing products being sent through a machine, which was presumably a metal detector. Although your response indicates that this machine was a metal detector, and you provide a metal detector drawing (dated November 19, 2015) that presumably depicts the equipment shown in the video, the video does not provide a complete view of the equipment to allow us to confirm what is being shown. Further, you did not provide any metal detection monitoring records to document the results of the metal detection activity purportedly being shown in the video."

Another issue was environmental pathogens as a hazard but did not put in proper sanitation preventive controls. 

[The company] "did not implement your sanitation preventive control for the environmental pathogens hazard. Your food safety plan identifies environmental pathogens as a hazard requiring a preventive control at various processing steps, such as mixing, tumbling, coating, and packaging, where the RTE “Java Jolt Blender Bombs” are exposed to the environment. These steps occur prior to your products being sealed. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."

The company did not follow their own procedures on following corrective actions for a positive Listeria species finding.

You did not follow the corrective actions outlined in your Environmental Monitoring – Listeria procedures, dated June 1, 2021, when you were notified of a presumptive positive Listeria spp. finding on August 24, 2023, for which your facility waived confirmation. According to your Environmental Monitoring – Listeria procedures in effect at the time, when a positive Listeria spp. result occurred, your facility would conduct follow-up environmental sampling that consisted of “(b)(4) swabs total; (b)(4) swabs a day taken on (b)(4) consecutive production days” and send the swabs to a third-party laboratory for analysis. However, your Microbiological Swab Test Logs from August 24-26, 2023, showed that a total of only (b)(4) swabs were taken ((b)(4) swab per day) instead of the required (b)(4) swabs total. Furthermore, instead of sending the swabs to your third-party laboratory for analysis, you tested the swabs in-house.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/golden-grains-bakery-688860-12202024
Golden Grains Bakery

MARCS-CMS 688860 — December 20, 2024
Recipient:
Marc L. Singer, Owner
Ronald L. Nadel, Owner
Golden Grains Bakery
547 Griffith Road
Charlotte, NC 28217-3517
United States