Inspections, Compliance, Enforcement, and Criminal Investigations
Kennys Farmhouse Cheese 12/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District OfficeCentral Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
WARNING LETTER CIN-13-347998-08
December 11, 2012
VIA UPS OVERNIGHT
Kenneth J. Mattingly, Owner
Kenny’s Farmhouse Cheese
2033 Thomerson Park Road
Austin, KY 42123
Dear Mr. Mattingly:
From August 6 – 8, 2012, the U.S. Food and Drug Administration (FDA) inspected your cheese manufacturing facility located at 2033 Thomerson Park Road, Austin, KY. During the inspection, FDA collected one environmental sample consisting of 85 swabs of food contact and non-food contact surfaces. FDA laboratory analyses of this sample confirmed the presence of Listeria monocytogenes (“L. monocytogenes”) in 29 swabs from a combination of food contact and non-food contact areas. In addition, FDA investigators observed significant violations of the Current Good Manufacturing Practice (CGMP) regulation for manufacturing, packing, or holding human food, found in Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations and the presence of L. monocytogenes in your manufacturing facility cause the foods manufactured at your facility to be 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 become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
Additionally, on August 30, 2012, FDA collected three finished product samples—771205 (Tomme de Nena Cheese), 731243 (Kentucky Bleu Cheese), and 731240 (Awe-Brie Cheese)—in which laboratory analyses confirmed the presence of L. monocytogenes. This finding renders these cheese products adulterated within the meaning of section 402(a)(1) [21 U.S.C. § 342(a)(1)] of the Act, in that they contain a poisonous or deleterious substance which may render them injurious to health.
Adulteration from Listeria Monocytogenes
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
On August 6, 2012, FDA collected one environmental sample consisting of 85 swabs from various food contact and non-food contact surfaces in your firm’s processing room, packaging room, spiral freezer, and storage freezer. Twenty-nine (29) of the 85 environmental swabs tested positive for L. monocytogenes. Of the swabs that tested positive, 12 were collected directly from food contact surfaces, and the remaining 17 were collected from non-food contact surfaces.
On August 29, 2012, we called your firm to advise you that our testing had resulted in isolation of L. monocytogenes from your facility. During this conversation, your firm committed to take the following steps: hire a consultant to assist with establishing a swabbing program, finished testing program, and cleaning SOPs and SOPs in general; re-clean and sanitize the creamery and other rooms; remove some wood materials from the creamery and replace them with plastic or materials that can be cleaned and sanitized; and work on the traffic control in the facility to try to minimize movement back and forth between rooms during production.
On August 30, 2012, FDA returned to your facility to collect samples of five different finished products. FDA’s laboratory analysis of the samples revealed the presence of L. monocytogenes in three of those samples: sample 771205, Tomme de Nena Cheese; sample 731243, Kentucky Bleu Cheese; and sample 731240, Awe-Brie Cheese. Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that L. monocytogenes isolates obtained from the FDA environmental samples collected on August 6, 2012 were indistinguishable by both a primary and secondary enzyme with finished products Awe-Brie Cheese, Kentucky Bleu Cheese, and Tomme de Nena Cheese collected on August 30, 2012. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and established niche areas. The presence of a persistent strain of L. monocytogenes in your facility over time is significant in that it demonstrates that sanitation efforts were inadequate to remove this pathogenic organism.
On October 3, 2012 we informed you of the laboratory findings indicating the presence of L. monocytogenes in three samples of your finished products. You explained that you would recall all product distributed from those lots. However, based on the presence of L. monocytogenes in your facility and the CGMP violations discussed below, it is apparent that your firm operates under insanitary conditions.
Violations of Current Good Manufacturing Practice
During the inspection that ended on August 8, 2012, FDA investigators observed the following significant CGMP violations:
- You failed to take effective measures to exclude pests from the processing areas as required by 21 CFR 110.35(c). On August 6 – 7, 2012 our FDA investigators observed live and dead flies in cheese vat #1, the creamery make room, the waxing room, the brine tank, cooler storage, and the packaging and shipping room. During the inspection, you verbally committed to being more diligent about spraying for flies and ensuring that the company would take more effective measures to exclude flies, and you initiated corrective action by spraying for flies during the inspection. Since the end of the inspection, however, we have received no written explanation of the measures you intend to take on an ongoing basis to alleviate this problem, nor have you provided documentation that the problem has been resolved.
- You failed to handle work-in-progress in a manner that protects against contamination as required by 21 CFR 110.80(b)(5). On August 6, 2012, during production of Asiago cheese, we observed one of your employees stirring cheese curds in vat #2 with bare hands. During the closeout meeting, you verbally committed to ensuring that all employees would be properly gloved during cheese production. Since the end of the inspection, however, we have received no written explanation of the measures you intend to take on an ongoing basis to alleviate this problem, nor have you provided documentation that the problem has been resolved.
- Your plant is not constructed in a manner to prevent condensate from contaminating food contact surfaces as required by 21 CFR 110.20(b)(4). Our FDA investigators observed condensate dripping onto finished product and dripping from the pipes, ceiling, and wall in the waxing room. During the closeout meeting, you verbally committed to take the following measures, within one week, in an attempt to prevent condensate from contaminating food contact surfaces: adjusting the temperature a few degrees higher in the brine room, placing a better seal on the brine room door, caulking the walls to the brine room, and insulating the overhead pipes and mounting the overhead pipes to the ceiling to eliminate dripping condensate in both the waxing room and aging and finished cooler storage. Since the end of the inspection, however, we have received no documentation that such actions have been completed and no written explanation of the measures you intend to take on an ongoing basis to alleviate this problem, nor have you provided documentation that the problem has been resolved.
- You failed to store your ingredients in containers designed and constructed so as to protect against contamination as required by 21 CFR 110.80(a)(5). The FDA investigators observed three boxes of ingredients stored directly on the floor in the aging and the finished product storage cooler. During the inspection, you verbally committed to storing the ingredients off the ground, effective immediately. Since the end of the inspection, however, we have received no documentation that the problem has been resolved.
- You failed to use cleaning compounds and sanitizing agents in a safe manner as required by 21 CFR 110.35(b)(1). The sanitizing solution in the three-compartment sinks in the packaging and shipping room and in the creamery had chlorine concentrations above 200 ppm. Chlorine concentrations above 200 ppm potentially cause residue that can become a food contaminant. During the inspection, you verbally committed to purchase chlorine test strips and train all employees how to properly mix and test the concentration of all sanitizing solutions. Since the end of the inspection, we have seen no documentation that the problem has been resolved or of what steps you have taken to resolve the issue.
The above violations are not meant to be an all-inclusive list of violations that may exist at your facility or with respect to your products. It is your responsibility to assure that your facility and your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to implement procedures to prevent such violations from recurring. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Please also include documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700 ext. 2163.
Paul J. Teitell
Paul J. Teitell