FDA inspected the ready-to-eat soft and semi-soft cheese (RTE) manufacturing facility located at 1330 Empire Avenue, Benton Harbor, Michigan from September 13, 2022 to October 6, 2022. check has been done...see moreInitiated in conjunction with MDARD during a multi-state outbreak of Listeria monocytogenes (L. monocytogenes) infections linked to RTE cream cheese products served at the facility. According to the CDC, six (6) patients from six (6) states were infected with the outbreak strain of Listeria monocytogenes. On September 30, 2022, the company recalled all of RTE's Brie and Camembert soft cheese products due to possible Listeria monocytogenes contamination. On October 5, 2022, the company expanded the recall to include baked brie. One (1) environmental swab isolate collected by FDA during its inspection of the manufacturing facility was consistent with the outbreak clinical isolate based on whole genome sequencing (WGS) analysis. According to the CDC, epidemiological, traceability, and laboratory data indicate that cheese from Old Europe Cheese, Inc. can make people sick. During an inspection of the facility, FDA found significant violations of current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls regulations (CGMP and PC rules) for human food. At the conclusion of the inspection, FDA issues Form FDA 483, Inspection Opinion, detailing the noncompliance found at the facility. FDA received email responses from the company dated October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023. They said they have voluntarily suspended operations while they conduct root cause investigations, improve facilities and revise your food safety program. Their responses so far suggest that production will remain suspended while long-term infrastructure projects are implemented and food safety systems are rebuilt. Based on FDA's review of the inspection results and the responses provided by the company, FDA is issuing this letter to inform them of FDA's concerns and to provide details describing the findings of the facility's investigation.
During an inspection of the facility, FDA found significant violations of current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls regulations (CGMP and PC rules) for human food.
At the conclusion of the inspection, FDA issues Form FDA 483, Inspection Opinion, detailing the noncompliance found at the facility. FDA received email responses from the company dated October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023. They said they have voluntarily suspended operations while they conduct root cause investigations, improve facilities and revise your food safety program. Their responses so far suggest that production will remain suspended while long-term infrastructure projects are implemented and food safety systems are rebuilt. Based on FDA's review of the inspection results and the responses provided by the company, FDA is issuing this letter to inform them of FDA's concerns and to provide details describing the findings of the facility's investigation.
Hazard Analysis and Risk-Based Preventive Controls
1. They did not adequately assess known or reasonably foreseeable hazards to determine whether they required precautionary testing for their RTE soft and semi-soft cheese products, including Brie and Camembert, as required by 21 CFR 117.130. control. special:
A. Their hazard analysis of soft and semi-soft cheese products concluded that "post-pasteurization contamination" does not require a preventive control because its occurrence layer, and the plant performance history indicates that the process is well controlled.” Additionally, their hazard analysis concluded that “environmental contamination (Listeria)” does not require preventive controls because “the environmental program used to test for Listeria” already in place. Finished product testing is also performed through an active release program. "However, the RTE soft and semi-soft cheese products produced at this facility were exposed to the environment at various stages of processing after pasteurization. The packaged RTE cheese products did not receive further lethal treatment nor did they contain any other significant Pathogen reduction controls (e.g. pathogen lethal formulations). Knowledgeable individuals who produce/process food in their environment will recognize contamination with environmental pathogens (e.g. Listeria monocytogenes) as a need for preventive controls ( Hazards known as Sanitation Controls). Sanitation Controls include procedures, practices, and processes to ensure that a facility maintains an adequate state of sanitation to significantly reduce or prevent hazards such as environmental pathogens and biological hazards from handling employees.
B. Their hazard analysis for soft and semi-soft cheese products concluded that "pathogens (Salmonella, Listeria), if present" do not require preventive controls in the "cold storage" step because "cold Control procedures" are in place. The facility has had no issues with room temperature in the past. "However, if RTE soft and semi-soft cheese products are stored in this facility without proper time/temperature control, they may promote the growth of bacterial and toxin-forming pathogens (e.g., survive pasteurization or Pathogens transmitted by ingredients added afterwards). Pasteurization or environmental pathogens introduced into your facility). Their RTE soft and semi-soft cheese products are not subject to any formulation controls at the facility to prevent this growth. In their case Bacterial pathogens are recognized by knowledgeable individuals who produce/process food as hazards that require preventive controls (i.e., process controls). Process controls include procedures, practices, and processes to ensure that parameters are controlled during operations such as refrigeration of finished products. In appropriate Where applicable, process controls shall also include parameters related to hazard control and the minimum and maximum values or combination of values required to achieve significant control of the hazard.These controls must be verified in accordance with 21 CFR 117.160.
C. Their hazard analysis of soft and semi-soft cheese products found Bacterial pathogens are not required for preventative control because "products have been tested for Salmonella - a Certificate of Authenticity received with each batch." These ingredients have not undergone a kill step in your facility. Knowledgeable people who produce/process food in their situation will identify bacterial pathogens as hazards requiring preventive controls (i.e. supply chain planning). During the FDA inspection, they said that by June 2022, lab personnel had tested each batch of ingredients for coliform colonies. Stop the test program at this point. Since then, the purchasing department has received a certificate of analysis (COA) for the ingredients, which are immediately ready for production.
For RTE products that require preventive controls for bacterial pathogens associated with ingredients (such as RTE seasonings) and do not undergo a kill step at this facility, they must establish and implement a supply chain plan in accordance with 21 CFR 117.405. Supply chain planning includes approving suppliers and conducting appropriate supplier screening activities. Salmonella in RTE spices is a hazard that can cause serious damage to health or cause death. Therefore, annual on-site audits are appropriate supplier verification activities unless documented findings indicate that other verification activities and/or less frequent supplier on-site audits provide reasonable assurance that hazards are controlled. Audits must be conducted prior to the use of a supplier's raw materials or any other ingredients and at least annually thereafter.
2. They have not implemented preventive controls to ensure that all hazards requiring preventive controls are significantly reduced or prevented, and soft and semi-soft cheese products (including Brie and Camembert cheese) is manufactured, processed, and packaged in accordance with the requirements of 21 CFR 117.135(a), and the facility may not adulterate under section 402 of the act. Specifically: You have not fully implemented sanitation measures related to soft cheese production at the RTE (post-pasteurization) stage.
FDA received their status updates on October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023 stating that they have not resumed operations and are currently working with their advisors, Identify and revise cleaning and sanitation procedures, condensation controls, environmental monitoring procedures, and employee training to close sources of Listeria in the facility. Their responses included various draft procedures including, but not limited to, standard operating procedures (SOPs) for hand washing, use of hoses, cleaning in place (CIP) of Brie equipment, pre-operational, draft sanitation and environmental monitoring procedures, facility ongoing A description of repair and construction work.
FDA will evaluate the adequacy of its corrective actions as they are completed and additional information is provided. FDA will review implementation the next time we inspect their facility.
current good manufacturing practice
3. You fail to clean and sanitize utensils and equipment in a manner that prevents contamination of food, food contact surfaces, or food packaging materials as required by 21 CFR 117.35. Specifically, on September 13, 2022, workers were observed spraying the exterior of the brie container and the floor surrounding the container with a hose, and the spray from the hose could be seen hitting the floor and then the associated adjacent cheese shaping machine. The machine (food contact surfaces) was not further cleaned or sanitized before being used to make Brie.
FDA has received a response from them stating that they have trained their staff on the proper handling and storage of the tubing and have made changes to their Sanitation Standard Operating Procedures (SSOP). In their January 13, 2023 response, they noted that their SSOP had been updated to include sanitation-related employee responsibilities and the frequency with which various SSOP activities were performed in product handling areas, and noted that the sequence of daily cleaning and sanitizing activities was detailed The general policy is in the production area. In their February 28, 2023 response, they noted that they were revising several sanitation procedures in the production and packaging areas. FDA will evaluate the adequacy of its corrective actions as they are completed and additional information is provided. FDA will review compliance at our next facility inspection.
4. Your facility is not designed such that dripping or condensation from fixtures, pipes, and piping will not contaminate food and food contact surfaces, as required by 21 CFR 117.20. In particular, from September 13-20, 2022, condensation was observed throughout the facility, including the cheese forming equipment and the area above the RTE brie.
FDA has received a response from them stating that they have assessed the facility for condensation, identified various improvements, and designed sanitation and monitoring procedures and are implementing them. FDA will evaluate the adequacy of its corrective actions as they are completed and additional information is provided. FDA will review implementation the next time we inspect their facility.
The violations identified in this letter do not constitute a comprehensive list of violations at this facility or its products. It is your responsibility to investigate to determine the cause of the violation described above and to prevent its recurrence or other violations. You are responsible for ensuring that your company complies with all requirements of federal law, including FDA regulations. You should take immediate action to correct the violations identified in this letter. Legal action for violations may be taken without prior notice, including but not limited to seizure, injunction or administrative action to suspend the registration of a food establishment subject to reasonable criteria and conditions.
Those ones:fda.gov website
About FDA Warning Letters: "When FDA determines that a manufacturer has committed a material violation of FDA regulations, FDA notifies the manufacturer. This notification usually takes the form of a warning letter. The warning letter identifies violations such as, for example, poor manufacturing issue or incorrect directions for use. The letter also clarifies the need for the company to address the issue and provides instructions and a timeline for the company to notify FDA of its corrective action plan."show less