FDA sends warning letter to food firm connected to...

FDA sends warning letter to food firm connected to death from listeriosis

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Multiple recalls, Campylobacter and Listeria outbreaks, and a death from listeriosis all in the past two years, have earned Swan Bros. Dairy the attention of the U.S. Food and Drug Administration.

Swan Brothers Dairy Inc. of Claremore, OK, is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations include the presence of Listeria monocytogenes in the firm’s facility.

According to the warning letter, the firm has been connected, by the Missouri Department of Health and Senior Services and the Oklahoma Department of Agriculture, Food and Forestry, to a patient hospitalized with listeriosis in 2021 who reported purchasing and consuming unpasteurized cow’s milk from the firm’s facility prior to becoming ill.  Two samples of unpasteurized milk products from the patient’s home were produced at Swan Brothers Dairy Inc.’s facility, one opened and refrigerated and one unopened and frozen were found to be contaminated with Listeria monocytogenes.

This patient died from listeriosis. 

The company Swan Bros. Dairy Inc. issued a statewide recall of raw milk after the ODAFF found Listeria in a sample in July of 2021. The company issued yet another recall of unpasteurized, raw milk because state officials found Listeria monocytogenes during a routine sample collected from the firm.

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

The husband of the Missouri woman who died from listeriosis filed a wrongful death lawsuit against Swan Brothers Dairy on Jan. 21, 2022.

This is not the first time or even the first year, Swan Brothers Dairy has had to recall there raw milk over contamination. On June 22, 2022, raw milk produced by Swan Bros. Dairy was subject to a statewide recall because of the confirmed detection of Campylobacter jejuni. As many as 10 individuals tested positive for the bacterial infection from these products. 

The warning letter

In the Jan. 28, 2022, warning letter the FDA described a July 26-30, 2021, inspection of Swan Brothers Dairy’s ready-to-eat (RTE) cheese manufacturing facility in Claremore, OK.

The FDA’s inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and resulted in the issuance of an FDA Form 483. The significant violations are as follows:

Pathogen Findings

In June 2021, Missouri Department of Health & Services (MDHSS) conducted an epidemiological investigation on a patient hospitalized with listeriosis who reported purchasing and consuming unpasteurized cow’s milk produced from the firm’s facility prior to becoming ill. This patient subsequently died from listeriosis. Further, MDHSS collected two samples of unpasteurized milk products from the patients’ home which were produced at their facility, one opened and refrigerated and one unopened and frozen.

The two unpasteurized milk samples were analyzed by the Missouri State Public Health Laboratory and confirmed the presence of Listeria monocytogenes. In response to MDHSS findings, the Oklahoma Department of Agriculture, Food, and Foresty (ODAFF) conducted a series of inspections at their facility and collected a series of product samples. As a result of ODAFF sampling conducted in June, July, October, and November 2021, 14 samples of milk and cheese products tested positive for Listeria monocytogenes. The 14 product samples included raw milk cheddar product, raw Colby cheese product, whole milk pasteurized product, raw whole milk product, raw skim milk product, raw 2 percent milk product, raw cream product, and raw milk product collected from the bulk tank.

FDA laboratory analysis of the environmental sample 1134355 collected on July 26, 2021, from various areas in their processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed that one swab out of 100 environmental swabs collected was positive for Listeria monocytogenes. The one swab was collected from a piece of wood located underneath the capper stand of their filler machine.

Whole genome sequencing (WGS) was conducted on the above-referenced Listeria monocytogenes isolates. The current WGS analysis determined that the one FDA environmental isolate is a genomic match to one clinical isolate collected in 2021, two unpasteurized milk isolates collected by the MDHSS in 2021, and 14 product isolates collected by the ODAFF in June, July, Oct., and Nov. 2021.

The presence of the same strain of Listeria monocytogenes in their environment and in food products from their facility over multiple months is indicative of a resident pathogen, according to the FDA. Further, the presence of the same strain in the product isolates, clinical isolate, and FDA environmental swab indicate that the environment is contributing to the contamination of their finished products and that this strain of L. monocytogenes is capable of causing illness.

On Sept. 17, 2021, FDA advised the company’s owners of the WGS results and MDHSS advised them of the results of their epidemiological investigation. Subsequently, the agency updated the WGS analysis to include the analysis of ODAFF product samples collected in October and November 2021.

The presence of Listeria monocytogenes in their facility and their products is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their facility to prevent contamination of food. Appropriate control of Listeria monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen.

FDA findings indicate that their firm is neither achieving satisfactory control against the presence of L. monocytogenes within their facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.

On July 30, 2021, Oct.  8, 2021, and Nov. 12, 2021, ODAFF issued the firm a Notice of Suspension of Permit based on findings of Listeria monocytogenes in their finished raw milk and raw milk products. Furthermore, on Dec. 6, 2021, ODAFF conducted an investigation and records review for their facility which found that in the last 24 months they were issued on four separate occasions a Notice of Suspension of Permit which involved recalls related to adulterated, pathogenic organisms present in their raw milk and raw milk products. Currently, ODAFF has not lifted the Nov. 12, 2021, Notice of Suspension; therefore, their permit to sell retail raw milk and retail raw milk products remains suspended.

Current Good Manufacturing Practice:

1. The firm did not maintain their plant in a clean and sanitary condition, as required. Specifically, during the inspection FDA investigators observed the following conditions:

a. After the (redacted) was cleaned, food residue, including protein film, was observed along milk level in the (redacted). their milk tank and the (redacted) are shared equipment used to process both raw and pasteurized milk and cheese products. 

b. There is no hard plumbing under their (redacted) compartment sinks, so water drains to the floor and flows across the processing rooms to their drains. Pooled water was observed near and on the cracked floors next to their milk filling machine and (redacted).

c. The firm’s exhaust fan and pulling string were rusty and dusty. The exhaust fan and pulling string are directly located over the storage area for cleaned cheese processing equipment.

d. The compartment attached to the (redacted) was in deteriorating condition with metal fragments, rust, and a mold-like substance present. Cleaning equipment and bushes were placed directly onto this compartment.

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

f. The wall, ceiling, floor and doors in their walk-in coolers were severely deteriorated, dusty, and stained with a mold-like substance.

g. Tape and plastic bags were used on processing equipment to cover overhead poles located directly over the (redacted) and on the motor or their milk filling machine.

h. A piece of wooden board used to support the bottom of their capper machine was stained with a mold-like substance, severely deteriorated, and soaked in wet pooled water. Additionally, their capper machine was rusty with peeling paint throughout the body of the machine.

2. The firm failed to exclude pests from their food plant to protect against contamination of food, as required.

Specifically, FDA investigators observed flies throughout their facility, including in the milk filling room and cheese processing room. These flies were observed landing on the food contact surfaces of their milk/cheese processing equipment including the milk filling machine, pipes for conveying milk, and inside the (redacted).

Further, FDA investigators noted that there is only one door separating their firm’s milk parlor where cows are milked from their milk filling room where raw and pasteurized milk are filled and stored. FDA investigators observed over 100 flies in their milk parlor areas, even when it was not in use. When their employees enter the milk filling room from the milk parlor, FDA investigators observed several flies flying entering into the room. Additionally, FDA observed gaps in their exterior doorway leading into the milk filling room, which are potential entry points for flies.

The firm’s response indicates that they are “planning on installing an air curtain device in the next 6 to 12 months and making sure the door is fully closed.” However, the firm did not indicate whether they will increase the (redacted) frequency of their pest control service, “(redacted),” to address the flies within their facility. 

3. The firm’s equipment and utensils were not designed to be adequately cleanable and maintained to protect against contamination, as required. Specifically, FDA investigators observed to following:

a. Cheese residues were on the hex heads of their cheese cutters.

b. The welds and seams on the milk filling machine and (redacted) were not smooth and easily cleanable.

c. The firm’s baskets, carry caddy, and cart used to store milk and cheese processing equipment were stained with mold-like substance, and their carry caddy was severely cracked and torn.

d. The uncapped ends of cleaned pipes used to convey milk for processing milk and cheese were touching the floor.

4. The firm failed to provide convenient hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, as required.

Specifically, FDA investigators observed that there were no hand-washing sinks installed in their milk filling room or their cheese processing room for employees to wash their hands prior to handling ready-to-eat products or milk/cheese processing equipment. Additionally, the only hand-washing sink is located in their toilet room where an employee must open 2 doors to return to the milk filling room or open 3 doors to return to the cheese processing room. Further, FDA investigators observed an employee dipping his hands into the sanitizer sink where utensils and equipment parts from milk/cheese processing equipment were being sanitized.

5. The firm failed to prevent drip or condensate from fixtures, ducts and pipes from contaminating food, as required. Specifically, FDA investigators observed condensation water dripping from the ceiling and fan vent onto the wooden shelves and onto shrink-wrapped cheese in the walk-in coolers. Some shrink-wrapped cheese is stored in cardboard boxes, and these boxes were wet.

6. The firm failed to fit each of their freezers used to store and hold food capable of supporting growth of microorganisms with an indicating thermometer, temperature-measuring device, or temperature-recording device to show the temperature accurately within the compartment, as required.

Specifically, their freezer units used to store cheese curds did not have any indicating thermometer, temperature-measuring device, or temperature-recording device. 

7. The firm failed to have accurate and precise instruments to measure or record temperatures, as required.

Specifically, the thermometer in their walk-in cooler #(redacted) indicated that the temperature was 36 degrees F but the FDA’s calibrated thermometer indicated that the temperature was 41 degrees F. Additionally, the thermometer was installed directly in front of blowing cold air from their refrigeration unit fan; such a location does not accurately reflect the temperature throughout the walk-in cooler. In their walk-in cooler #(redacted), their thermometer indicated that the temperature was 48 degrees F but the FDA’s calibrated thermometer indicated that the temperature was 45 degrees F.

The full warning letter can be viewed here.

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