WARNING LETTER
Old Europe Cheese, Inc.
MARCS-CMS 644539 —
March 17, 2023
Delivery Method:
VIA EMAIL WITH READ RECEIPT
Product:
Food & Beverages
Recipient:
Recipient Name
Albano Navarro
Recipient Title
General Manager
Old Europe Cheese, Inc.
1330 E. Empire Avenue
Benton Harbor
,
MI
49022-2018
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
FY23- HAFE6- 02 CMS 644539
March 17, 2023
Dear Mr. Navarro,
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) soft and semi-soft cheese manufacturing facility, located at 1330 E. Empire Avenue, Benton Harbor, MI, from September 13, 2022 through October 6, 2022. The inspection, conducted jointly with the Michigan Department of Agriculture and Rural Development (MDARD), was initiated as part of a multistate outbreak of
Listeria monocytogenes
(
L. monocytogenes
) infections linked to RTE soft cheese products supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), six (6) ill people from six (6) states were infected with the outbreak strain of
L. monocytogenes
. On September 30, 2022, your 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 your firm expanded the recall to also include Baked Brie Cheeses. One (1) environmental swab isolate collected by FDA during our inspection of your 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 our inspection of your 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), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on our inspectional findings, we have determined that the RTE Brie and Camembert Soft 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. The introduction or delivery for introduction into interstate commerce of an adulterated food is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at
http://www.fda.gov.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility. We received your email responses, dated October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023. You indicated that you have voluntarily suspended operations while you conduct a root cause investigation, make facility improvements, and revise your food safety plan. Your responses to date have indicated that production will remain suspended while you implement long-term infrastructure projects and rebuild your food safety systems. We have addressed the details of your responses in this letter below. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility.
Multistate Outbreak of Listeriosis Linked to Old Europe Cheese, Inc.
CDC, FDA, and State partners investigated this multistate outbreak of
L. monocytogenes
infections linked to RTE soft cheese products produced by Old Europe Cheese, Inc. This investigation included six (6) ill people in six (6) states who were infected with the outbreak strain of
L. monocytogenes
. Of six (6) patients with information available, five (5) were hospitalized. Food exposure information was collected for five (5) patients, and four (4) patients reported consumption of brie or camembert cheese. One (1) 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 (2) 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 September 13 and 14, 2022, FDA collected samples (environmental swabs) of your production environment. FDA laboratory analysis of sample INV1084040 confirmed that (1) swab collected from a hole in the
(b)(4)
floor was positive for
L. monocytogenes
, and we advised you of this result on September 23, 2022.
WGS analysis was conducted of the above referenced
L. monocytogenes
isolate and it was determined that the environmental isolate matched the six (6) clinical isolates that were part of an illness outbreak cluster. We advised you of the significance of these WGS results via conference call on September 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
L. monocytogenes
infections.
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.
The presence of
L. monocytogenes
in your facility 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.
We received your email responses, dated October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023, outlining the corrective actions you have taken in response to the
L. monocytogenes
outbreak and sample findings. On September 30, 2022, your firm initiated a voluntary recall of your RTE Brie and Camembert Soft Cheese products and you expanded the recall to include Baked Brie on October 5, 2022. After the product recalls and in response to FDA’s laboratory data indicating that products manufactured at your facility were the likely source of this outbreak of
L. monocytogenes
infections, your 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 October 5, 2022, to facilitate a root cause investigation within your entire facility. You began implementing corrective actions after the initial notification of the environmental sampling results on September 23, 2022, which included cleaning, sanitation, and environmental vector sampling. Thus far, you have provided results for swabs collected on September 17-18, 2022,
(b)(4)
samples and swabs of
(b)(4)
collected on September 25, 2022,
(b)(4)
samples. We also note that you 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 your floors, drains, walls, and ceilings. However, to date, your responses have not provided evidence that you have eliminated
L. monocytogenes
from your processing environment or effectively prevented it from contaminating finished products you may manufacture in the future.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. You did not appropriately evaluate known or reasonably foreseeable hazards to determine whether they require a preventive control in your RTE soft and semi-soft cheese products (including Brie and Camembert), as required by 21 CFR 117.130(a)(1). Specifically:
a. Your 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, your 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 your facility were exposed to the environment at various post-pasteurization processing steps (e.g.,
(b)(4)
). 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 your 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 (see 21 CFR 117.135(c)(3)).
FDA laboratory analysis of the environmental samples collected on September 13 and 14, 2022 (Samples INV1084039 and INV1084040, respectively), confirmed that one (1) out of
(b)(4)
total environmental swabs was positive for
L. monocytogenes
. This positive swab was recovered from a hole in the floor of your
(b)(4)
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
L. monocytogenes
, the presence of L
isteria innocua
(
L. innocua
) was also found in your facility during the FDA environmental swabbing that occurred on September 13 and 14, 2022.
L. innocua
was detected in two (2) environmental swabs taken from the floor in the
(b)(4)
Room and a floor drain between the
(b)(4)
Room and
(b)(4)
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
L. monocytogenes
which, as noted above, has been found in your facility.
b. Your 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 your 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). Your RTE soft and semi-soft cheese products were not subject to formulation control in your facility to prevent such growth. A knowledgeable person manufacturing/processing food in your 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 (see 21 CFR 117.135(c)(1)). These controls must be validated as required by 21 CFR 117.160.
We note that your Cooler Temperature Control program did not include written procedures including monitoring, corrective actions, or verification activities for the temperature control of your cooler, which routinely stores RTE soft cheese products including Brie and Camembert. Also, during the inspection, our investigators observed that monitoring cooler temperature only occurred
(b)(4)
on weekdays and
(b)(4)
on weekends. Additionally, through record review during the inspection, we detected two (2) 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
L. monocytogenes
, when not stored at proper refrigeration temperatures.
c. Your 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 your circumstances would identify bacterial pathogens as a hazard requiring a preventive control (i.e., supply-chain program). During our inspection, you 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 your facility, you are required to establish and implement a supply-chain program in accordance with 21 CFR 117.405(a)(1). A supply-chain program includes approving suppliers and conducting appropriate supplier verification activities as described in 21 CFR 117.410.
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 (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).
We received the revised hazard analysis provided with your October 28, 2022, response which now identifies hazards requiring a preventive control, including recontamination with environmental pathogens at your post-pasteurization steps and pathogen growth during cooler storage. Further, we note that your Raw Ingredient Hazard Analysis now includes hazards related to pathogenic bacteria (including
Salmonella
) for various ingredients, and that you are in the process of conducting supplier risk assessments and identifying a verification activity. Your response dated February 28, 2023, included your “Draft Preventive Control Temperature Monitoring Program” and associated draft procedures related to cooler temperature monitoring. Your draft monitoring procedures indicate that temperature data loggers are
(b)(4)
monitoring the cooler and that there is
(b)(4)
. Your draft procedures appear to indicate that the
(b)(4)
check corresponds to a single point in time, rather than a review of the temperatures for the entire period since the last check. Therefore, reviewing the data logger temperature data on a
(b)(4)
basis does not appear adequate to ensure prompt corrective actions are taken when the temperature exceeds established maximum limits.
2. You 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 your facility will not be adulterated under section 402 of the Act, as required by 21 CFR 117.135(a). Specifically:
Your sanitation procedures were not fully implemented with respect to the production of soft cheeses when they are RTE (post-pasteurization). For example:
Your 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 September 13, 2022, our investigators observed two (2) different employees’ hands come into contact with unclean surfaces (e.g., a hose that had been in contact with the floor); these employees
(b)(4)
their hands into a
(b)(4)
and returned directly to handling RTE brie cheese without washing their hands.
Your Master Sanitation Schedule directed employees to clean-in-place (CIP) the brie vats with both
(b)(4)
solution according to the production schedule. However, our investigators observed during the CIP on September 15, 2022, that the vat was only filled to approximately
(b)(4)
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 your employees also indicated that
(b)(4)
solution is not always used in the vats during the week, contrary to the instructions in the Master Sanitation Schedule.
The objectives of your 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 September 13, 2022 and September 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 your Sanitation SOP required a visual inspection of processing equipment and verification of sanitation effectiveness (with
(b)(4)
swabbing) prior to use of the equipment (including food-contact surfaces). However, your Lab Preop Worksheets indicated that these activities were not performed as directed during several days in 2022. For example, neither visual inspection nor
(b)(4)
swabbing was performed on the brie vats, utensils, knives, brie
(b)(4)
, molding trays, and brie
(b)(4)
(food-contact surfaces) in five (5) out of seven (7) days of the week beginning May 29, 2022. Likewise, the same activities did not occur on five (5) out of seven (7) days of the week beginning June 5, 2022.
Your Environmental Swabbing program required collection of a minimum of
(b)(4)
samples from designated zone 2-4 locations every
(b)(4)
. However, you collected ten (10) swabs on or around May 25, 2022, and then you stated that you did not collect any more swabs until the week of this inspection, on or around September 14, 2022.
We received your status updates provided on October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023, indicating that you have not resumed operations and are in the process of working with your consultants to evaluate the source of
Listeria
in your facility, as well as revising your cleaning and sanitation procedures, condensation control, environmental monitoring procedures, and employee training. Your 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.
We will evaluate the adequacy of your corrective actions once they have been completed and additional information is provided. We will verify implementation during our next inspection of your facility.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
3. You 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(a). 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.
We received your responses which indicate that you conducted employee training on proper operation and storage of hoses and made changes to your Sanitation SOPs (SSOP). Your January 13, 2023, response states that your 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. Your February 28, 2023, response states that you are revising numerous sanitation procedures for the production area and the packaging area. We will evaluate the adequacy of your corrective actions once they have been completed and additional information is provided. We will verify implementation during our next inspection of your facility.
4. Your 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(b)(4). Specifically, on September 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
(b)(4)
Room
(b)(4)
. Condensation was also visible on the walls and windows near the ceiling of the
(b)(4)
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
(b)(4)
Room.
We received your responses which indicate that you have evaluated condensation in your facility, identified various improvements, and drafted sanitation and monitoring procedures and that you are in the process of implementing. We will evaluate the adequacy of your corrective actions once they have been completed and additional information is provided. We will verify implementation during our next inspection of your facility.
The violations in this letter are not intended to be an all-inclusive list of violations that may exist at your facility or in connection with your products. You 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 your firm complies with all requirements of federal law, including FDA regulations. You 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.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
If you believe that your products are not in violation of the Act, Include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent to Lauren Sexton, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Lauren Sexton at (313) 393-8179 or via e-mail at Lauren.Sexton@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6
Content current as of:
04/04/2023
Regulated Product(s)
Food & Beverages