As part of its enforcement activities, the Food and Drug Administration 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.
Old Europe Cheese, Inc.
Benton Harbor, MI
A food firm in Michigan is on notice from the FDA for serious violations inside their ready-to-eat cheese facility, including the presence of Listeria that matches the outbreak strain. The outbreak sickened six and hospitalized five. The outbreak’s connection to the firm led to multiple recalls.
In a March 17, 2023, warning letter, the FDA described a Sept. 13 through Oct. 6, 2022, FDA inspection of Old Europe Cheese, Inc.’s ready-to-eat (RTE) soft and semi-soft cheese manufacturing facility in Benton Harbor, MI.
The FDA’s inspection revealed that the firm was not in compliance with Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practice regulations and resulted in the issuance of an FDA Form 483.
Significant violations:
Multistate Outbreak of Listeriosis Linked to Old Europe Cheese, Inc.
The CDC, FDA, and State partners investigated this multistate outbreak of Listeria monocytogenes infections linked to RTE soft cheese products produced by Old Europe Cheese, Inc. This investigation included six ill people in six states who were infected with the outbreak strain of Listeria monocytogenes. Of six patients with information available, five were hospitalized. Food exposure information was collected for five patients, and four patients reported consumption of brie or camembert cheese. One case reported purchasing Premium Cheese by Lidl brie. Old Europe Cheese Inc. was the sole manufacturer of Premium Cheese by Lidl brie sold at stores in the U.S. Two other patients also reported purchasing unknown brands of brie/camembert; these two cases each reported shopping from a store which also received cheese products from Old Europe Cheese Inc.
On Sept. 13 and 14, 2022, FDA collected samples (environmental swabs) of their production environment. FDA laboratory analysis of sample INV1084040 confirmed that one swab collected from a hole in the (redacted) floor was positive for Listeria monocytogenes, and FDA advised them of this result on Sept. 23, 2022.
WGS analysis was conducted of the above referenced Listeria monocytogenes isolate and it was determined that the environmental isolate matched the six clinical isolates that were part of an illness outbreak cluster. FDA advised them of the significance of these WGS results via conference call on Sept. 28, 2022.
Epidemiologic, traceback, and laboratory data support a conclusion that cheese products manufactured at Old Europe Cheese, Inc. are the likely source of this outbreak of Listeria monocytogenes infections. Listeria 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 Listeria 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.
The presence of Listeria monocytogenes in their facility 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 received the firm’s email responses, dated Oct. 28, 2022, Nov. 30, 2022, Jan. 13, 2023, and Feb. 28, 2023, outlining the corrective actions they have taken in response to the Listeria monocytogenes outbreak and sample findings. On Sept. 30, 2022, their firm initiated a voluntary recall of their RTE Brie and Camembert Soft Cheese products and they expanded the recall to include Baked Brie on Oct. 5, 2022. After the product recalls and in response to FDA’s laboratory data indicating that products manufactured at their facility were the likely source of this outbreak of Listeria monocytogenes infections, their firm voluntarily suspended production of soft cheeses. Voluntary suspension of all production in the facility (including semi-soft cheese products that are manufactured on separate equipment located in a different room than the brie cheese) occurred on Oct. 5, 2022, to facilitate a root cause investigation within their entire facility. The firm began implementing corrective actions after the initial notification of the environmental sampling results on Sept. 23, 2022, which included cleaning, sanitation, and environmental vector sampling. Thus far, they have provided results for swabs collected on Sept. 17-18, 2022, (redacted) samples and swabs of (redacted) collected on Sept. 25, 2022, (redacted) samples. The FDA also notes that the have hired a food safety consultant and are in the process of conducting a root cause investigation, developing and/or updating multiple food safety procedures including environmental monitoring procedures, and making improvements to their floors, drains, walls, and ceilings. However, to date, their responses have not provided evidence that they have eliminated Listeria monocytogenes from their processing environment or effectively prevented it from contaminating finished products they may manufacture in the future.
Hazard Analysis and Risk-Based Preventive Controls
1. The firm did not appropriately evaluate known or reasonably foreseeable hazards to determine whether they require a preventive control in their RTE soft and semi-soft cheese products (including Brie and Camembert). Specifically:
a. The firm’s hazard analysis for soft and semi-soft cheese products determined that “Post-Pasteurization Contamination” did not require a preventive control because it was “Unlikely to occur as purity plating of production samples is performed and plant performance history indicates good process control.” In addition, their hazard analysis determined that “Environmental Contamination (Listeria)” did not require a preventive control because an “Environmental program is in place to test for listeria spp. Finished product testing is also performed with positive release program.” However, RTE soft and semi-soft cheese products manufactured in their facility were exposed to the environment at various post-pasteurization processing steps (e.g., (redacted). The packaged RTE cheese products did not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens (e.g., Listeria monocytogenes) as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling.
FDA laboratory analysis of the environmental samples collected on Sept. 13 and 14, 2022, confirmed that one out of (redacted) total environmental swabs was positive for Listeria monocytogenes. This positive swab was recovered from a hole in the floor of their (redacted) Room, where the cheese products are RTE (post-pasteurization), exposed to the environment, and manually handled by employees. WGS analysis of this isolate determined it was a match to the outbreak strain.
In addition to Listeria monocytogenes, the presence of Listeria innocua was also found in their facility during the FDA environmental swabbing that occurred on Sept. 13 and 14, 2022. Listeria innocua was detected in two environmental swabs taken from the floor in the (redacted) Room and a floor drain between the (redacted) Room and (redacted) Hallway where the cheese products are RTE (post-pasteurization) and exposed to the environment. The presence of non-pathogenic Listeria species suggests that conditions are suitable for survival and/or growth of Listieria monocytogenes which, as noted above, has been found in their facility.
b. The firm’s hazard analysis for soft and semi-soft cheese products determined that “Pathogens (Salmonella, Listeria), if present” did not require a preventive control at the “Cooler Storage” step because a “Program for Cooler Temperature [sic] Control is in place. Plant does not have a history of problematic room temperatures.” However, if not properly time/temperature-controlled, the RTE soft and semi-soft cheese products stored in their facility are likely to support the growth and toxin formation of bacterial pathogens (such as ingredient-related pathogens either surviving pasteurization or added post-pasteurization, or environmental pathogens introduced in their facility). Their RTE soft and semi-soft cheese products were not subject to formulation control in their facility to prevent such growth. A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as refrigerated finished product storage. Where appropriate, process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values, or combination of values, needed to significantly control the hazards. These controls must be validated.
The FDA notes that their Cooler Temperature Control program did not include written procedures including monitoring, corrective actions, or verification activities for the temperature control of their cooler, which routinely stores RTE soft cheese products including Brie and Camembert. Also, during the inspection, FDA investigators observed that monitoring cooler temperature only occurred (redacted) on weekdays and (redacted) on weekends. Additionally, through record review during the inspection, FDA detected two dates where temperatures were recorded as 51.2°F, 52°F and 53.1°F with no record of a corrective action documented. Soft cheeses can support the growth of pathogens, including Listeria monocytogenes, when not stored at proper refrigeration temperatures.
c. The firm’s hazard analysis for soft and semi-soft cheese products determined that bacterial pathogens in many ingredients added after pasteurization (e.g., peppercorns, 1/8” flaked tomato, chives, basil, garlic salt, and parsley) did not require a preventive control because “Product is tested for Salmonella – COA Received per lot.” These ingredients did not undergo a kill step in their facility. A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control (i.e., supply-chain program). During FDA inspection, they explained that every lot of ingredients was tested for the presence of coliform colonies by laboratory personnel until June 2022, at which point the testing program was discontinued. Since that time, the certificates of analysis (COAs) for ingredients had been received by the purchasing department, and the ingredients were made immediately available for use in production.
For those RTE products that require a preventive control for bacterial pathogens associated with the ingredients (i.e., RTE spices) and that do not undergo a kill step within their facility, they are required to establish and implement a supply-chain program. A supply-chain program includes approving suppliers and conducting appropriate supplier verification activities. Salmonella in RTE spices is a hazard that can cause serious adverse health consequences or death, and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled. The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter.
2. The firm did not implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the RTE soft and semi-soft cheese products (including Brie and Camembert) manufactured, processed, packed, or held by their facility will not be adulterated. Specifically:
Their sanitation procedures were not fully implemented with respect to the production of soft cheeses when they are RTE (post-pasteurization). For example:
- The firm’s sanitation procedures, as described in the document titled, “GMP Manual,” instructed employees to wash their hands “following practices that may compromise hand cleanliness.” However, on Sept; 13, 2022, FDA investigators observed two different employees’ hands come into contact with unclean surfaces (e.g., a hose that had been in contact with the floor); these employees (redacted) their hands into a (redacted) and returned directly to handling RTE brie cheese without washing their hands.
- Their Master Sanitation Schedule directed employees to clean-in-place (CIP) the brie vats with both (redacted) solution according to the production schedule. However, FDA investigators observed during the CIP on Sept. 15, 2022, that the vat was only filled to approximately (redacted) of its volume, which resulted in the food-contact surfaces inside not being fully submerged, as would be needed to facilitate effective cleaning. One of their employees also indicated that (redacted) solution is not always used in the vats during the week, contrary to the instructions in the Master Sanitation Schedule.
- The objectives of their Sanitation SOP included ensuring “that all food- and non-food contact surfaces are free from soil after manufacturing/processing” and “will not negatively affect food quality and food safety.” However, on Sept. 13, 2022 and Sept. 20, 2022, food-contact cheese molds used for manufacturing RTE Brie and Camembert cheeses were observed to have food residue present after cleaning was completed.
- Post-sanitation/Pre-operation procedures in their Sanitation SOP required a visual inspection of processing equipment and verification of sanitation effectiveness (with (redacted) swabbing) prior to use of the equipment (including food-contact surfaces). However, their Lab Preop Worksheets indicated that these activities were not performed as directed during several days in 2022. For example, neither visual inspection nor (redacted) swabbing was performed on the brie vats, utensils, knives, brie (redacted), molding trays, and brie (redacted) (food-contact surfaces) in five out of seven days of the week beginning May 29, 2022. Likewise, the same activities did not occur on five out of seven days of the week beginning June 5, 2022.
- Their Environmental Swabbing program required collection of a minimum of (redacted) samples from designated zone 2-4 locations every (redacted). However, they collected 10 swabs on or around May 25, 2022, and then they stated that they did not collect any more swabs until the week of this inspection, on or around Sept. 14, 2022.
Current Good Manufacturing Practice:
3. The firm did not conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. Specifically, on Sept. 13, 2022 employees were observed spraying the outside of brie vats and the floor around the vats with a hose in such a manner that spray from the hose was observed contacting the floor and subsequently contacting the adjacent cheese molding machine. This machine (a food-contact surface) did not receive further cleaning or sanitization prior to being used to mold brie cheese.
4. The firm’s plant is not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food and food-contact surfaces. Specifically, on Sept. 13-20, 2022, condensation was observed throughout the facility including on areas above cheese molding equipment and RTE brie cheese. For example, condensation and dark reddish-brown stains were observed on the ceiling directly over at least ten racks of stacked food-contact cheese molds stored in the Clean Room. Clear condensation was also observed on pipes and the ceiling within two feet of exposed RTE brie cheese in (redacted) Room (redacted). Condensation was also visible on the walls and windows near the ceiling of the (redacted) Room where food-contact cheese molds were observed sitting on racks exposed to the environment in this room for approximately three hours before being moved to the (redacted) Room.
The full warning letter can be viewed here.
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