The U.S. Food and Drug Administration (FDA) has issued warning letters to three food manufacturers: Ice Cream House LLC in Brooklyn, NY; NRS Enterprises, Inc. d/b/a Sunflour Bakery in Costa Mesa, CA; and Brewing Market Coffee in Boulder, CO. Each company was cited for significant food safety violations that could pose serious risks to public health.
Ice Cream House LLC
Brooklyn, NY
The FDA’s warning letter to Ice Cream House LLC, dated Sept. 24, 2024, followed an inspection from Feb. 21 through March 26, 2024, revealing the presence of Listeria monocytogenes in the facility. This inspection came in response to a 2023 multistate outbreak linked to the company’s ice cream products, which led to two hospitalizations. At the conclusion of the inspection, the FDA investigators issued the facility a Form FDA 483, Inspectional Observations.
The letter noted that Listeria monocytogenes was found on food-contact surfaces in the production area, indicating that the company’s sanitation controls were inadequate to prevent contamination. The FDA further highlighted the company’s failure to implement proper allergen controls and its lack of effective supply-chain monitoring.
The full warning letter can be viewed here.
NRS Enterprises, Inc. d/b/a Sunflour Bakery
Costa Mesa, CA
In a Aug. 13, 2024, warning letter to Sunflour Bakery, the FDA cited the bakery for multiple violations during an inspection from Feb. 15 to March 6, 2024. These violations included failure to implement a food safety plan and improper labeling of bakery products, leading to a recall of three products because of undeclared allergens. At the conclusion of the inspection, the FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their firm.
The FDA found that the bakery’s manufacturing environment was not being maintained in a sanitary condition, with evidence of pest activity and cross-contact between products containing different allergens. The letter also noted that the company had failed to establish adequate controls to prevent contamination from environmental pathogens.
Pests:
Flying insects observed around various locations, including food-contact surfaces.
Cockroaches: Both dead and live cockroaches found in holding areas and near sinks.
Other Violations:
Undeclared allergens in products.
Lack of proper controls for allergen cross-contact.
Failure to identify environmental pathogens as hazards.
Insufficient cleaning of non-food-contact surfaces and equipment.
Equipment not designed for adequate cleanability and maintenance.
Misbranding issues related to labeling and nutrition information.
The full warning letter can be viewed here.
Brewing Market Coffee
Boulder, CO
The FDA issued a warning letter on April 25, 2024, to Brewing Market Coffee in Boulder, CO, following an inspection of its acidified beverage production facility from Dec. 14, 2023 through Jan. 25, 2024. The inspection revealed that the company’s acidified chai teas, including its Ginger Chai Tea, were manufactured under conditions that did not comply with federal safety standards for acidified foods. At the conclusion of the inspection, the FDA investigator issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility.
The FDA found that Brewing Market Coffee failed to submit scheduled process information for its shelf-stable chai teas and did not ensure that employees responsible for pH controls had completed FDA-approved training. Additionally, the company was cited for improperly calibrating pH meters and failing to measure pH levels after products reached equilibrium, which could result in unsafe products.
The full warning letter can be viewed here.
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