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WARNING LETTER

Swan Brothers Dairy Inc MARCS-CMS 619346 —


Delivery Method:
UPS Overnight
Product:
Food & Beverages

Recipient:
Recipient Name
Diane Williamson
Recipient Title
President/Owner
Swan Brothers Dairy Inc

938 E 5th Street
Claremore, OK 74017
United States

Issuing Office:
Office of Human and Animal Food Operations West Division 3

United States


WARNING LETTER
CMS Case # 61934


January 28, 2022

Dear Ms. Williamson:

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) cheese manufacturing facility located at, 938 E 5th Street, Claremore, Oklahoma, from July 26, 2021 through July 30, 2021. In addition to manufacturing RTE cheese products, you also produce unpasteurized and pasteurized milk. Our inspection was initiated after Oklahoma Department of Agriculture, Food and Forestry (ODAFF) was notified of a report from Missouri Department of Health and Senior Services (MDHSS) which documented that an individual was hospitalized with listeriosis after purchasing and consuming raw cow’s milk from your firm. Subsequently, you conducted a voluntary recall of your unpasteurized milk and cheese products.

During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of L. monocytogenes, a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.

Based on FDA’s inspectional findings, we have determined that your RTE cheese products manufactured in your facility 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 been contaminated with filth or rendered injurious to health. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

On August 6, 2021, you submitted a Qualified Facility Attestation for Human Food Facility. Additionally, we received your written responses on August 20, 2021, August 24, 2021, and September 11, 2021, which describe your completed and planned corrective actions. After reviewing the inspectional findings and responses you provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Pathogen Findings

L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

In June 2021, MDHSS conducted an epidemiological investigation on a patient hospitalized with listeriosis who reported purchasing and consuming unpasteurized cow’s milk produced from your facility prior to becoming ill. This patient subsequently passed away from listeriosis. Further, MDHSS collected two (2) samples of unpasteurized milk products from the patients’ home which were produced at your facility, one opened and refrigerated and one unopened and frozen. The two (2) unpasteurized milk samples were analyzed by the Missouri State Public Health Laboratory and confirmed the presence of L. monocytogenes. In response to MDHSS findings, ODAFF conducted a series of inspections at your facility and collected a series of product samples. As a result of ODAFF sampling conducted in June, July, October, and November 2021, fourteen (14) samples of milk and cheese products tested positive for L. monocytogenes. The fourteen (14) product samples included your raw milk cheddar product, raw Colby cheese product, whole milk pasteurized product, raw whole milk product, raw skim milk product, raw 2% 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 your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed that one (1) swab out of one hundred (100) environmental swabs collected was positive for L. monocytogenes. The one (1) swab was collected from a piece of wood located underneath the capper stand of your filler machine.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates. The current WGS analysis determined that the one (1) FDA environmental isolate is a genomic match to one (1) clinical isolate collected in 2021, two (2) unpasteurized milk isolates collected by the MDHSS in 2021, and fourteen (14) product isolates collected by the ODAFF in June, July, October, and November 2021.

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

On September 17, 2021, FDA advised you of the WGS results and MDHSS advised you 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 L. monocytogenes in your facility and your products is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. Appropriate control of L. 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. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your 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.

Your written responses do not clearly outline the corrective actions you have taken or plan to take to address our L. monocytogenes findings within your environment. Your response included laboratory analytical worksheets but failed to include any written descriptions providing context to these analysis or corrective actions you have taken to address our findings. Based on your response, we are unable to evaluate the adequacy and implementation of your corrective actions. Further, we remain strongly concerned about the food products being manufactured in your facility.

On July 30, 2021, October 8, 2021, and November 12, 2021, ODAFF issued you a Notice of Suspension of Permit based on findings of L. monocytogenes in your finished raw milk and raw milk products. Furthermore, on December 6, 2021, ODAFF conducted an investigation and records review for your facility which found that in the last 24 months you were issued on four (4) separate occasions a Notice of Suspension of Permit which involved recalls related to adulterated, pathogenic organisms present in your raw milk and raw milk products. Currently, ODAFF has not lifted the November 12, 2021, Notice of Suspension; therefore, your permit to sell retail raw milk and retail raw milk products remains suspended.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. You did not maintain your plant in a clean and sanitary condition, as required by 21 CFR 117.35(a). Specifically, during our inspection our investigators observed the following conditions:

a. After the (b)(4) was cleaned, food residue, including protein film, was observed along milk level in the (b)(4). Your milk tank and the (b)(4) are shared equipment used to process both raw and pasteurized milk and cheese products. According to your firm management, you have not implemented any extensive cleaning or sanitizing procedures to ensure that there is no cross contamination between processing raw milk products and pasteurized milk products.

b. There is no hard plumbing under your (b)(4) compartment sinks, so water drains to the floor and flows across the processing rooms to your drains. Pooled water was observed near and on the cracked floors next to your milk filling machine and (b)(4).

c. Your 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 (b)(4) 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, celling, floor and doors in your 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 (b)(4) and on the motor or your milk filling machine.

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

Your firm’s response addresses some of these observations. Specifically, you indicate that the “exhaust fan and string will be cleaned,” you will “store cleaning equipment by hanging on the wall,” “walls, ceiling, and doors will be cleaned and repaired in the next 6-12 months,” and “wood under capper machine will be replaced in the next 6-12 months.” However, you did not provide further detail on how you plan to implement or maintain these corrective actions. Additionally, your corrective actions also indicate that you “have always implemented cleaning and sanitizing procedures to ensure no cross contamination between raw and pasteurized products,” and “there has never been an incidence where phosphatase has been detected in pasteurized products above the allowance.” However, you did not provide additional detail regarding how you clean and sanitize your equipment or whether you had any plans to sequence your product manufacturing to reduce the potential for contamination. Furthermore, you did not provide any corrective actions to address the observed food residue, the pooling water and floor drainage, the deteriorating conditions of the compartment attached to your (b)(4), and the tape and plastic bags on you processing equipment. We strongly advise you to take corrective actions to address these violations. We will verify the adequacy of your corrective actions during our next inspection.

2. You failed to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c).

Specifically, our investigators observed flies throughout your facility, including in the milk filling room and cheese processing room. These flies were observed landing on the food contact surfaces of your milk/cheese processing equipment including the milk filling machine, pipes for convey milk, and inside the (b)(4).

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

Your firm’s response indicates that you are “planning on installing an air curtain device in the next 6 to 12 months and making sure the door is fully closed.” However, you did not indicate whether you will increase the (b)(4) frequency of your pest control service, “(b)(4),” to address the flies within your facility. Additionally, you did not provide any corrective actions to address the gaps within your exterior doorway. We will verify the adequacy of these corrective actions during our next inspection.

3. Your equipment and utensils were not designed to be adequately cleanable and maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). Specifically, our investigators observed to following:

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

b. The welds and seams on the milk filling machine and (b)(4) were not smooth and easily cleanable.

c. Your baskets, carry caddy, and cart used to store milk and cheese processing equipment were stained with mold-like substance, and your 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.

Your firm’s response indicates that you are planning to dishwash your cheese cutters, reweld the seams and welds on your equipment, purchase new baskets to store parts for your equipment, and install caps for hoses which are not in use. Your proposed corrective action lacks details on how frequently you will clean the cutter and how you plan to maintain its cleanliness to protects against contamination. We will verify the adequacy of these corrective actions during our next inspection.

4. You 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 by 21 CFR 117.37(e).

Specifically, our investigators observed that there were no hand-washing sinks installed in your milk filling room or your 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 your 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, our investigators observed an employee dipping his hands into the sanitizer sink where utensils and equipment parts from milk/cheese processing equipment were being sanitized.

Your firm’s response indicates that you are “planning on installing hand washing stations in the next 6 to 12 months.” There were not additional details provided on where these hand washing sinks will be located. Further, no documentation was provided to verify the progression or completion of your proposed corrective actions. We will verify the adequacy of these corrective actions during our next inspection.

5. You failed to prevent drip or condensate from fixtures, ducts and pipes from contaminating food, as required by 21 CFR 117.20(b)(4). Specifically, our 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.

Your firm’s response indicates that “cheese boxes were removed from the area where condensation was dripping;” however, you do not provide any corrective actions or indicate how you will address the condensation drip. We strongly advise you to take corrective actions to address this violation.

6. You failed to fit each of your 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 by 21 CFR 117.40(e).

Specifically, your freezer units used to store cheese curds did not have any indicating thermometer, temperature-measuring device, or temperature-recording device. Your corrective action indicates that “thermometers will be installed in freezer units.” However, you did not provide any supporting evidence to document any changes that have been implemented. We will verify the adequacy of these corrective actions during our next inspection.

7. You failed to have accurate and precise instruments to measure or record temperatures, as required by 21 CFR 117.40(f).

Specifically, the thermometer in your walk-in cooler #(b)(4) indicated that the temperature was 36F but the FDA’s calibrated thermometer indicated that the temperature was 41F. Additionally, the thermometer was installed directly in front of blowing cold air from your refrigeration unit fan; such location does not accurately reflect the temperature throughout the walk-in cooler. In your walk-in cooler #(b)(4), your thermometer indicated that the temperature was 48F but the FDA’s calibrated thermometer indicated that the temperature was 45F.

Your corrective action indicates that “thermometers in cold storage rooms will be moved to a proper location.” However, you did not provide any corrective actions to address how you will address the accuracy and precision of your thermometers. We strongly advise you to take corrective actions to ensure that your thermometers are measuring the temperatures in your cold storage units accurately and precisely.

The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to do so may results in legal action by the FDA without further notice, including without limitation, seizure and injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please respond in writing within 15 working days of your receipt of this letter of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.

Your written response should be sent to Casey L. Hamblin, Recall Coordinator/Compliance Officer, U.S. Food and Drug Administration, One Main Place, 1201 Main Street, STE 7200, Dallas, TX 75202. If you have any questions regarding the content of this letter, please contact Mrs. Hamblin at 214-253-5222 or Casey.Hamblin@fda.hhs.gov.

Sincerely,
/S/

Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director

Cc:

Pete Echelle, Director of Dairy Services
Oklahoma Department of Agriculture, Food and Forestry
2800 N. Lincoln Blvd.
Oklahoma City, OK 73105

 
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