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FDA sends warning letter to food companies linked to listeriosis deaths

Multiple recalls, Campylobacter and Listeria outbreaks, and deaths from listeriosis over the past two years have brought Swan Brothers Dairy to the attention of the FDA.

Swan Brothers Dairy Inc. of Claymore, Oklahoma, was notified by the FDA for serious violations of current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations. These violations included the presence of Listeria monocytogenes in company facilities.

According to the warning letter, the company has contacted the Missouri Department of Health and Senior Services and the Oklahoma Department of Agriculture, Food and Forestry for a 2021 hospitalization with listeriosis patient, who reported purchasing and consuming unpasteurized milk from the company’s facilities prior to becoming ill. Swan Brothers Dairy Inc.’s facility produced two samples of unpasteurized dairy products from patients’ homes, one opened and refrigerated, the other unopened and frozen and found to be infected with Listeria monocytogenes Pollution.

The patient died of listeriosis.

Swan Bros. Dairy Inc. is recalling raw milk statewide after ODAFF found Listeria in samples in July 2021. The company is again recalling unpasteurized raw milk after state officials found Listeria monocytogenes in routine samples taken from the company.

The warning letter states that FDA investigators believe the facility’s environment is contributing to the contamination of its finished products.

On January 21, 2022, husband of Missouri woman who died of listeriosis filed wrongful death lawsuit against Swan Brothers Dairy.

This is not the first time, not even the first year, that Swan Brothers Dairy has had to recall contaminated raw milk there. On June 22, 2022, raw milk produced by Swan Brothers Dairy was recalled statewide due to confirmed detection of Campylobacter jejuni. As many as 10 individuals have tested positive for bacterial infection from these products.

Warning Letter

On January 28, 2022, the FDA describes the warning letter as July 26 An inspection of Swan Brothers Dairy’s ready-to-eat (RTE) cheese manufacturing facility in Claremore, Oklahoma, 2021-30.

FDA’s inspection found serious violations of current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations and resulted in the issuance of FDA Form 483. Major violations are as follows:

Pathogen Discovery

June 2021, Missouri Department of Health and Services ( MDHSS) conducted an epidemiological investigation of a patient hospitalized with listeriosis who reported purchasing and consuming unpasteurized milk produced at the company’s facilities. Get ill. The patient subsequently died of listeriosis. In addition, MDHSS collected two samples of unpasteurized dairy products produced in their facility from patients’ homes, one unopened and refrigerated, and one unopened and frozen.

Two unpasteurized milk samples were analyzed by the Missouri Public Health Laboratory and confirmed the presence of Listeria monocytogenes. In response to the MDHSS findings, the Oklahoma Department of Agriculture, Food and Forestry (ODAFF) conducted a series of inspections of its facilities and collected a series of product samples. As a result of ODAFF sampling in June, July, October and November 2021, 14 samples of milk and cheese products tested positive for L. monocytogenes. 14 product samples including raw milk cheddar dairy products, raw Colby cheese products, whole pasteurized dairy products, raw whole dairy products, raw skimmed dairy products, raw 2% dairy products, whipped cream products and from bulk cans Collection of raw dairy products.

FDA Laboratories analyzed environmental sample 1134355 collected on July 26, 2021 from various areas of its processing facility, including food contact surfaces and areas adjacent to food contact surfaces, One swab was confirmed to be positive for Listeria monocytogenes out of 100 environmental swabs collected. One swab was collected from a piece of wood located under its filler capper stand.

Whole genome sequencing (WGS) was performed on the L. monocytogenes isolates described above. The current WGS analysis identified an FDA environmental isolate with a clinical isolate collected in 2021, two unpasteurized milk isolates collected in 2021 by MDHSS, and ODAFF in June, July, 10 Genomic matches of 14 product isolates collected in November 2021.

According to the FDA, the presence of the same L. monocytogenes strain in their environment and food in their facility for several months indicates the presence of a resident pathogen. Additionally, the presence of the same strains in product isolates, clinical isolates, and FDA environmental swabs indicates that the environment is contributing to contamination of their finished products, and this L .

On September 17, 2021, FDA informs company owners of WGS results and MDHSS informs them of epidemiological findings. Subsequently, the agency updated the WGS analysis to include analysis of ODAFF product samples collected in October 2021 and November 2021. Sanitation efforts are insufficient to effectively control pathogens in their facilities to prevent food contamination. Appropriate control of L. monocytogenes in a food processing environment requires understanding the unique characteristics of the organism and implementing the corresponding sanitation measures required to control this pathogen.

FDA findings indicate that their company has neither achieved satisfactory control of the presence of Listeria monocytogenes in their facilities nor implemented effective methods and controls to eliminate this human pathogen or minimize contact surfaces with food and food. Once it is established in the production area, personnel or equipment can facilitate the movement of pathogens and contamination of food contact surfaces and finished products. Hiding points in food processing plants and equipment where the organism can grow and survive must be identified and the necessary corrective actions taken to eradicate the organism.

On July 30, 2021, October 8, 2021, and November 12, 2021, ODAFF issued an update based on its findings of Listeria monocytogenes in finished raw milk and raw dairy products. The company issued a notice to suspend the license. Additionally, ODAFF conducted an investigation and records review of their facility on December 6, 2021, and found that they had issued license suspension notices four times in the past 24 months involving recalls related to the presence of adulterated pathogens in their raw milk and raw milk products. Currently, ODAFF has not lifted the 12 November 2021 suspension notice; therefore, their retail raw milk and retail raw milk products sales licenses remain suspended.

Current Good Manufacturing Practice:

1. The company did not keep the factory clean and hygienic as required. Specifically, during the inspection, FDA investigators observed the following:

a. After cleaning (redacted), food residues including protein films were observed along the milk level in (redacted). Their milk tanks and (REDACTED) are shared equipment used to process raw and pasteurized milk and cheese products.

b. Their (redacted) cubicle has no hard pipes under the sink, so the water drains to the floor and flows through the processing chamber to their sewers. Standing water was observed near their milk filler and (REDACTED).

c next to the cracked floor. The company’s exhaust fans and drawstrings were rusted and dusty. Exhaust fans and drawstrings are located directly above the storage area for cleaning cheese processing equipment.

d. (REDACTED) The compartments on are in a deteriorated state with metal chips, rust and mold-like substances. Cleaning equipment and shrubs are placed directly on this compartment.

e. Hoses used to flush milk and cheese processing equipment were observed in pool water on the floor.

f. Walls, ceilings, floors and doors in their walk-in coolers were badly damaged, dusty and stained with a mold-like substance.

g. Use tape and plastic bags on the handling equipment to cover the ejector bars located on (REDACTED) and the motor or its milk filling machine.

H. A piece of wood that supports the bottom of the capper was soiled with a mold-like substance, badly deteriorated, and soaked in damp pool water. Also, their capping machine is rusted and the paint is peeling throughout the machine.

2. The company failed to remove pests from its food plants as required to prevent food contamination.

Specifically, FDA investigators observed flies throughout its facility, including in the milk filling room and cheese processing room. These flies were observed to land on food contact surfaces of their milk/cheese processing equipment, including milk fillers, pipes that transport milk, and inside of (REDACTED) .

In addition, FDA investigators noted that only a door separates their company’s milking parlour from the milk filling room, which fills and stores raw and pasteurized milk. FDA investigators observed more than 100 flies in their dairy area, even when not in use. When their employees entered the milk filling room from the dairy, FDA investigators observed several flies flying into the room. Additionally, the FDA observed gaps in the outer door leading to the milk filling chamber, a potential entry point for flies.

The company’s response indicated that they “plan to have the door fully closed over the next 6 to 12 months.” However, the company did not say whether it would increase ( redacted) frequency of pest control services, “(redacted)” to address fly problems in their facility.

3. The company’s equipment and utensils were not adequately cleaned and maintained as required to prevent contamination. Specifically, FDA investigators observed:

a. Cheese residue is on the hex head of their cheese cutter.

b. Welds and seams on milk filler and (edited) are not smooth and easy to clean.

c. The company’s baskets, carts and carts used to store milk and cheese processing equipment were stained with mold-like substances, and the carts were severely cracked and torn.

d. The uncapped end of the clean pipe used to convey milk for processing milk and cheese touches the floor.

4. The company failed to provide convenient handwashing facilities as required to ensure that employees’ hands did not become a source of contamination of food, food contact surfaces or food packaging materials.

Specifically, FDA investigators observed that their milk filling room or cheese processing room did not have hand basins installed for employees to wash their hands before handling ready-to-eat products or milk/cheese processing equipment. Also, the only sinks are in the restrooms and employees have to open 2 doors to return to the milk filling room or 3 doors to return to the cheese processing room. Additionally, FDA investigators observed an employee dipping his hand into a sanitizing sink where utensils and equipment parts in a milk/cheese processing facility were being sanitized.

5. The company failed as required to prevent dripping or condensation from fixtures, pipes and pipes from contaminating food. Specifically, FDA investigators observed condensation dripping from ceiling and fan vents onto wood shelves and onto shrink-wrapped cheese in walk-in coolers. Some shrink-wrapped cheeses are stored in cardboard boxes, which are wet.

6. The company failed to equip each freezer used to store and preserve food capable of supporting microbial growth, as required, with an indicating thermometer, temperature measuring device or temperature recording device to accurately display the interval temperature in the room.

Specifically, the freezers they use to store cheese curds do not have any indicating thermometers, temperature measuring devices, or temperature recording devices.

7. The company failed to have accurate and precise instruments to measure or record temperature as required.

Specifically, the thermometer in their walk-in cooler # (redacted) indicated a temperature of 36 degrees F, but the FDA ‘s calibrated thermometer shows a temperature of 41 degrees Fahrenheit. In addition, the thermometer is mounted directly in front of the cooling unit fan blowing cold air; such a location does not accurately reflect the temperature of the entire walk-in cooler. In their walk-in cooler #(redacted), their thermometer reads 48F, but the FDA’s calibrated thermometer reads 45F.

The full warning letter can be viewed here.

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