Old Europe Cheese Inc, 1330 East Empire Avenue, Benton Harbor, MI 49022, United States

jointly with MDARD, was initiated as part of a multistate outbreak of Listeria monocytogenes (L. monocytogenes) infections linked to RTE soft cheese products supplied by this facility. According to the CDC, six (6) ill people from six (6) states were infected with the outbreak strain of L. monocytogenes. On September 30, 2022, this firm recalled all RTE Brie and Camembert Soft Cheese products because they had the potential of being contaminated with L. monocytogenes. On October 5, 2022 this firm expanded the recall to also include Baked Brie Cheeses. One (1) environmental swab isolate collected by FDA during the inspection of this manufacturing facility matched the clinical outbreak isolates, based on Whole Genome Sequencing (WGS) analysis. According to the CDC, epidemiologic, traceback, and laboratory data showed that cheese made by Old Europe Cheese, Inc. made people sick.

During the inspection of this facility, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule).

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at this facility. The FDA received the company email responses, dated October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023. They indicated that they have voluntarily suspended operations while they conduct a root cause investigation, make facility improvements, and revise your food safety plan. Their responses to date have indicated that production will remain suspended while they implement long-term infrastructure projects and rebuild their food safety systems. Based on FDA review of the inspectional findings and the responses that this firm provided, FDA is issuing this letter to advise them of FDA’s concerns and to provide detailed information describing the findings at this facility.

Hazard Analysis and Risk-Based Preventive Controls

1. They 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), as required by 21 CFR 117.130. Specifically:

a. Their 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 this facility were exposed to the environment at various post-pasteurization processing steps. 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., L. 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.
b. Their 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 this 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 your facility). Their RTE soft and semi-soft cheese products were not subject to formulation control in this 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 (i.e., process controls). 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 as required by 21 CFR 117.160.
c. Their 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 your 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 this facility, they are required to establish and implement a supply-chain program in accordance with 21 CFR 117.405. 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. They 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 this facility will not be adulterated under section 402 of the Act, as required by 21 CFR 117.135(a). Specifically: Their sanitation procedures were not fully implemented with respect to the production of soft cheeses when they are RTE (post-pasteurization).

FDA received their status updates provided on October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023, indicating that they have not resumed operations and are in the process of working with their consultants to evaluate the source of Listeria in this facility, as well as revising their cleaning and sanitation procedures, condensation control, environmental monitoring procedures, and employee training. Their responses included various draft procedures including, but not limited to, Standard Operating Procedures (SOPs) for handwashing, use of hoses, brie equipment clean-in-place (CIP), pre-operation, draft sanitation and environmental monitoring procedures as well as descriptions of ongoing facility repairs and construction.
FDA will evaluate the adequacy of their corrective actions once they have been completed and additional information is provided. FDA will verify implementation during our next inspection of their facility.

Current Good Manufacturing Practice
3. They 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, as required by 21 CFR 117.35. Specifically, on September 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.

FDA received their responses which indicate that they conducted employee training on proper operation and storage of hoses and made changes to their Sanitation SOPs (SSOP). Their January 13, 2023, response states that their SSOPs have been updated to include employee responsibilities regarding sanitation and the frequency with which various SSOP activities are performed in product handling areas, and indicates that the general policy details the sequence of routine cleaning and sanitizing activities in production areas. Their February 28, 2023, response states that they are revising numerous sanitation procedures for the production area and the packaging area. FDA will evaluate the adequacy of their corrective actions once they have been completed and additional information is provided. FDA will verify implementation during our next inspection of your facility.

4. Their 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, as required by 21 CFR 117.20. Specifically, on September 13-20, 2022, condensation was observed throughout the facility including on areas above cheese molding equipment and RTE brie cheese.
FDA received their responses which indicate that they have evaluated condensation in this facility, identified various improvements, and drafted sanitation and monitoring procedures and that they are in the process of implementing. FDA will evaluate the adequacy of their corrective actions once they have been completed and additional information is provided. FDA will verify implementation during our next inspection of their facility.

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

Source: www.fda.gov

About FDA Warning letters: "When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction."