FDA warns food processors about Listeria, allergen and sanitation violations

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

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The FDA has issued warning letters to three food processing companies— Kingdom Creamery of Vermont LLC, One Roof LLC, and Breadbox Co. — for significant violations of federal food safety regulations. These violations, identified during inspections in 2024, raise concerns about potential health hazards, including Listeria monocytogenes contamination, allergen mislabeling and inadequate sanitation practices.

Kingdom Creamery of Vermont LLC
East Hardwick, VT

The FDA issued a warning letter on Dec. 26, 2024, to Kingdom Creamery of Vermont LLC, following an inspection from Aug. 6 to 27, 2024, at its ready-to-eat (RTE) dairy product manufacturing facility in East Hardwick, VT. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), alongside the presence of Listeria monocytogenes in the facility, rendering its RTE dairy products, including ice cream and frozen yogurt mix bases, adulterated.

Critical violations:

• Listeria monocytogenes contamination: Environmental swabs collected on Aug. 6, 2024, confirmed L. monocytogenes on a non-food contact surface (a hose handle and nozzle). This pathogen was also detected in environmental swabs and product samples from 2022, 2023 and 2024, with whole genome sequencing (WGS) indicating a resident strain linked to clinical illnesses in 2021 and 2022.
• Sanitation failures: Employees were observed handling soiled equipment and moving between pre- and post-pasteurization areas without washing hands or changing gloves, risking cross-contamination. Hoses sprayed mist onto damaged floors, contacting RTE product surfaces. Condensate from overhead pipes dripped onto packaging materials.
• Facility maintenance issues: Cracked floors, improper storage of cleaning brushes, and ice buildup in freezers were noted, alongside an unpaved driveway contributing to insanitary conditions.
• Inaccurate records: Sanitation records were pre-filled and did not reflect actual conditions.

FDA action and next steps
The company’s September 2024 responses outlined corrective actions, including low-pressure wands, overhead hose reels, and improved record-keeping, but the FDA remains concerned about persistent Listeria monocytogenes and inadequate sanitation. The agency will verify corrective actions in future inspections. Failure to comply could lead to seizure, injunction, or suspension of food facility registration.

The full warning letter can be viewed here.

One Roof LLC
Baltimore, MD

The FDA issued a warning letter on May 20, 2025, to One Roof LLC, following an inspection from Oct. 24 to Dec. 9, 2024, at its RTE food manufacturing facility in Baltimore, MD. Initiated after a voluntary recall of Atwater’s Spider Web Tarts due to undeclared almonds, the inspection uncovered violations of the CGMP & PC rule and labeling regulations, rendering products like Dark Chocolate Walnut Cookies and Spider Web Tarts adulterated and misbranded.

Critical violations:

• Inadequate hazard analysis: No hazard analysis was conducted for Dark Chocolate Walnut Cookies or Spider Web Tarts, failing to address allergens, environmental pathogens, mycotoxins or metal hazards.
• Allergen control failures: Shared equipment used for almond-containing products was not adequately cleaned, leading to cross-contact. The Spider Web Tarts recall was due to undeclared almond flour. Labels also failed to meet nutritional and ingredient declaration requirements.
• Sanitation issues: Sanitizer solutions were below effective concentrations, and employees failed to wash hands or change gloves after handling dirty equipment.
• Environmental pathogens: Presumptive Listeria spp. was found in environmental swabs, with no documented corrective actions. Non-pathogenic Listeria innocua was detected in five swabs, indicating conditions conducive to pathogen growth.
• Mycotoxin and metal hazards: No supply-chain controls existed for mycotoxins in ingredients like walnuts, and a damaged dough mixer auger posed a metal contamination risk.

FDA action and next steps
The company’s Dec. 24, 2024, response included a hazard analysis for Dark Chocolate Walnut Cookies and training plans, but lacked documentation for Spider Web Tarts and supplier verification. The FDA will verify corrective actions in future inspections. Non-compliance could result in seizure or injunction.

The full warning letter can be viewed here.

Breadbox Co.
Santa Fe Springs, CA

The FDA issued a warning letter on Nov. 18, 2024, to Breadbox Co., following an inspection from May 10 to June 7, 2024, at its RTE bakery product manufacturing facility in Santa Fe Springs, CA. The inspection revealed serious violations of the CGMP & PC rule, rendering products including breads, muffins and bagels adulterated.

Critical violations:

• No food safety plan: The facility lacked a food safety plan, including hazard analysis, preventive controls, and a recall plan, for its more than 1,900 bakery products.
• Allergen cross-contact: Sesame seeds were found on non-sesame breadsticks, and shared equipment was inadequately cleaned, risking allergen cross-contact.
• Undeclared color additives: FD&C Yellow #5 in Breadman Raisin Bread and Brioche was not declared, leading to recalls on May 16, 2024.
• Sanitation and pest issues: Dirty racks, soiled mittens, and food residue on equipment were observed. Insects were present in production areas, and facility conditions, including damaged ceilings and standing water, created harborage for pathogens.
• Facility maintenance: Splintered wooden baskets, damaged tables, and missing cove base tiles contributed to insanitary conditions.

FDA action and next steps
Breadbox Co. has not responded to the FDA-483 issued at the inspection’s conclusion. The FDA requests a written response within 15 days, detailing corrective actions. Failure to comply could lead to seizure or injunction.

The full warning letter can be viewed here.

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Source: https://www.foodsafetynews.com/2025/06/fda-warns-food-processors-about-listeria-allergen-and-sanitation-violations/