Middlefield Original Cheese Cooperative

WARNING LETTER Middlefield Original Cheese Cooperative MARCS-CMS 719761 — March 06, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Mr. Nevin R. Byler Recipient Title Manager Middlefield Original Cheese Cooperative 16942 Kinsman Rd Middlefield , OH 44062 United States Sunrisecreamery@plainconnect.com Issuing Office: Human Foods Program United States March 6, 2026 WARNING LETTER Re: CMS # 719761 Dear Mr. Byler: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) human food manufacturing facility, located at 16942 Kinsman Rd Middlefield, OH 44062 on August 12, 2025, through September 8, 2025. This inspection was initiated as a follow-up to a voluntary recall your firm conducted of cheese products due to your findings of pathogenic Listeria monocytogenes (L. monocytogenes) in cheese manufactured by your facility. During the 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 Regulations (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presences of L. monocytogenes , a human pathogen, in your facility. Based on FDA’s inspectional findings and analytical results for samples collected from your production environment, we have determined that the RTE cheese products manufactured in your facility are adulterated within the meaning 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 become contaminated with filth, or whereby they may have been rendered injurious to health. 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 FDA’s regulations through links on FDA’s homepage at www.fda.gov. At the conclusion of the inspection, FDA issued an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. On September 17, 2025, we received your firm’s responses to the FDA-483 via email, describing corrective actions taken and planned by your firm. Based on our review of the inspectional findings and the responses that you provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We discuss your responses below. Hazard Analysis and Risk-Based Preventive Controls Requirements (21 CFR Part 117, Subpart C) 1. You did not implement preventive controls in your food safety plan to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food 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)(1). Specifically, your hazard analysis for your various cheese products identifies the hazard of contamination with environmental pathogens such as “Bacterial Pathogens” such as Listeria, (b)(4) . Salmonella, (b)(4) , and/or (b)(4) as requiring a preventive control at the “ (b)(4) ” and the “ (b)(4) ” steps. Your sanitation preventive controls indicate that environmental monitoring is to be performed (b)(4) , sanitizer chemical concentrations are to be tested (b)(4) , and (b)(4) inspections are to be performed (b)(4) . However, FDA Investigators observed the following instances in which you failed to implement your procedures: a. A review of your records revealed that you had not conducted environmental monitoring during the (b)(4) of (b)(4) . This is a repeat deviation from the previous FDA inspection conducted on September 18, 2023 through September 27, 2023 during which it was observed you did not implement (b)(4) environmental monitoring activities as required by your environmental monitoring program. b. A review of your records revealed that you failed to test the concentration of your (b)(4) sanitizer during the (b)(4) . This (b)(4) sanitizer is used (b)(4) to sanitize your cheese processing equipment (b)(4) . Furthermore, preventive controls are subject to preventive control management components (monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR 117.140). We note that you did not have adequate controls in place for contamination with environmental pathogens regarding monitoring, corrective action and verification activities, as evidenced by the following observations during the inspection: c. A review of your environmental monitoring records revealed positive findings of L. monocytogenes in your facility on (b)(4) and again in repeat locations beginning on (b)(4) through (b)(4) . The repeat positive findings collected from the same locations indicate that your current corrective action strategy of cleaning, sanitizing, and re-swabbing until achieving negative results is inadequate for controlling environmental pathogens in your facility. d. FDA Investigators collected an environmental sample from your facility on August 12, 2025 during the manufacturing of (b)(4) cheese. The sample consisted of 80 environmental swabs collected from various surfaces in your (b)(4) room, which resulted in the finding of 14 positive swabs for L. monocytogenes . e. Your written environmental monitoring program, dated January 9, 2023, specifies the “corrective action for environmental monitoring positive listeria” for “Zone (b)(4) ” is to “…Clean equipment and resample for Listeria…”, “…Reclean and resample until negative sample” and “Conduct retraining for employee Sanitation.” However, your environmental monitoring program is inadequate because it does not include a procedure for determining the root cause of contamination and does not address product disposition after a positive result is reported, as required by 21 CFR 117.150(a)(2). f. The FDA investigators observed equipment in your (b)(4) room which lacked an adequately cleanable design which creates a food contamination risk. Specifically, the metal surfaces surrounding the underside of the (b)(4) were corroded and pieces of metal flaked off upon touching the surface. Your September 17, 2025 response identified the root cause of the L. monocytogenes finding in the plant as “… (b)(4) …” and “… (b)(4) …” and states that you took the corrective actions of (b)(4) . However, your response does not identify the source of the L. monocytogenes or include any evidence that an investigation was conducted to determine the source of contamination. Your response also does not include evidence to demonstrate that the referenced actions have been completed such as the updated environmental monitoring program, cleaning/sanitation procedures, corresponding monitoring records, and photographic evidence or a detailed description of what was cleaned and sanitized and how the tasks were completed to demonstrate the facility and equipment repairs were made. Furthermore, your response included a laboratory report, dated (b)(4) , capturing environmental monitoring results for (b)(4) swab sub-samples collected on (b)(4) . One collection of (b)(4) environmental swabs is not representative of a (b)(4) square foot facility as it does not provide adequate assurance that the L. monocytogenes found in your facility has been eliminated from the processing environment based on the severity of the findings in the environment and in finished product. 2. You did not review your process preventive control monitoring and verification records, as required by 21 CFR 117.165(a)(4). Specifically: a. From January 2025 through July 2025, your (b)(4) sanitation forms for the (b)(4) production room, plant packaging area, and (b)(4) room repeatedly lacked a signature, or included a signature with no date, to indicate who reviewed the records and when. b. From (b)(4) through (b)(4) your (b)(4) cleaning log lacked dates for record review. c. From April 2025 through August 2025, your (b)(4) “chemical concentration logs” lacked signatures capturing review. Your chemical concentration logs capture concentrations for detergents and sanitizers used for cleaning and sanitizing the manufacturing environment and equipment. d. Your (b)(4) test results for January 2, 2025, through August 19, 2025, lacked signatures or dates to indicate the results were reviewed. Your (b)(4) records capture the testing for the presence of antibiotic residues for your incoming raw milk. e. Your (b)(4) pasteurizer time and temperature monitoring charts contained review signatures but lacked review dates for charts dated (b)(4) and (b)(4) and (b)(4) . f. Your metal detector verification log lacked signatures or dates to indicate the logs were reviewed between (b)(4) through (b)(4) . This is a repeat deviation from the previous FDA inspection conducted on September 18, 2023 through September 27, 2023 which was discussed relating to the failure to consistently review your monitoring records. Your September 17, 2025 response states the root cause for the lack of monitoring and review of the preventive controls was “ (b)(4) ” with the corrective action of “… (b)(4) …”. Your response lacks evidence to demonstrate that the preventive controls are being adequately implemented, and the management components are being reviewed by (b)(4) . 3. For your RTE cheese products, your written recall plan does not describe the steps to be taken to directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food, or to notify the public about any hazard presented by the food when appropriate to protect public health, as required by 21 CFR 117.139(b). Furthermore, there are no assigned responsibilities for the individuals listed as part of the recall team to perform the above-mentioned actions. Your RTE cheese products have multiple known or reasonably foreseeable hazards requiring preventive controls (see 21 CFR § 117.139(a). On July 21, 2025, your facility initiated a recall of multiple cheese products due to positive results for L. monocytogenes in a sample of (b)(4) cheese product which your facility collected. On August 27, 2025, your facility initiated a second recall due to additional cheese samples testing positive for L. monocytogenes which your facility also collected. This is a repeat deviation from the previous FDA inspection conducted on September 18, 2023, through September 27, 2023 which was discussed relating to your recall plan lacking steps to notify consignees of a recall and assigning responsibilities for such steps. Your September 17, 2025 response identifies the root cause for the inadequate recall plan as “… (b)(4) ” with a resolution of “ (b)(4) .” However, this response is not complete because it does not include a recall plan with updated procedures and assigned responsibilities for those implementing them. Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B) 4. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically, on August 12, 2025, an FDA Investigator observed one live apparent cockroach on the end of a (b)(4) table. On August 28, 2025, they observed two live apparent cockroaches in electrical boxes on the wall next to the pasteurizer, three apparent live cockroaches under the edge of the (b)(4) , one dead apparent cockroach on the floor next to (b)(4) vat (b)(4) , and one live apparent cockroach on its back in the bottom of (b)(4) vat (b)(4) , which is a food contact surface. On August 13, 2025, the investigator observed approximately 12 apparent rodent excreta pellets and ants, too numerous to count, on the floor of the employee break room. Your employee breakroom is approximately (b)(4) feet down the hall from the (b)(4) production room and close to product storage cooler (b)(4) . Your September 17, 2025 response indicates that you (b)(4) , and states that the (b)(4) “…has an effective program…”. However, no evidence was provided to demonstrate the effectiveness of your corrective action. This letter is not intended to be an all-inclusive statement 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 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. This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address these violations 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. Please send your reply to the Food and Drug Administration, Attention: Daniel Johnson, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Daniel Johnson via email at: Daniel.Johnson@fda.hhs.gov Please include reference CMS #719761 on any submissions and within the subject line of any email correspondence to the agency. Sincerely, /S/ Maria S. Knirk, JD, MBA Acting Director Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 09/29/2026 Regulated Product(s) Food & Beverages