WARNING LETTER
Kingdom Creamery of Vermont LLC MARCS-CMS 693165 —
- Delivery Method:
- VIA UPS
- Product:
- Food & Beverages
- Recipient:
-
Recipient NameMr. Jeremey Michaud
-
Recipient TitleOwner
- Kingdom Creamery of Vermont LLC
3411 VT Route 16
East Hardwick, VT 05836-9630
United States
- Issuing Office:
- Human Foods Program
United States
December 26, 2024
WARNING LETTER
Ref: Case # 693165
Dear Mr. Michaud:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) dairy product manufacturing facility, located at 3411 VT Route 16, East Hardwick, VT, from August 6 through August 27, 2024. During our 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 regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, we collected environmental swabs from various areas in your processing facility and FDA laboratory analyses of these swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and the analytical results revealing L. monocytogenes in your production environment, we have determined that the RTE dairy products, including ice cream and frozen yogurt mix bases, 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 rendered injurious to health.
You may find the Act and further information about the CGMP & PC rule through links in FDA's homepage at www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You have provided responses to the FDA-483 on September 9 and 13, 2024, describing corrective actions taken by your firm. Based on our review of the inspectional findings, analytical results, and responses that your firm has 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.
L. monocytogenes Findings:
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, a foodborne illness, 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.
Our inspection included the collection of environmental swabs from various areas in your processing facility during production on August 6, 2024. FDA laboratory analysis of environmental swabs collected at your facility on August 6, 2024, confirmed that (b)(4) of the (b)(4) environmental swabs was positive for L. monocytogenes. The swab was collected from a non-food contact surface of the handle and nozzle on a red hose, which was placed on top of the black plastic table next to the bag fill station.
We note that this was not the first time L. monocytogenes was found in environmental swabs collected at your facility. In 2022, FDA detected L. monocytogenes in (b)(4) environmental swabs. Furthermore, you confirmed the presence of L. monocytogenes through your own testing of your processing environment in 2022, 2023, and 2024. Additionally, you detected the presence of L. monocytogenes in product samples that you collected in 2022, 2023, and 2024. You voluntarily submitted the isolates from the environmental swabs you collected in 2022, 2023, and 2024 and from finished products you collected in 2022, 2023, and 2024 to the FDA for further analysis and sequencing.
Whole genome sequencing (WGS) was conducted on the following L. monocytogenes isolates obtained from FDA environmental swabs, your environmental swabs, and your product samples, as follows:
• (b)(4) L. monocytogenes isolate obtained from FDA environmental swabs collected on August 6, 2024
• (b)(4) L. monocytogenes isolates obtained from your environmental swabs on August 20, 2023
• (b)(4) L. monocytogenes isolates obtained from FDA environmental swabs collected on July 11, 2022
• (b)(4) L. monocytogenes isolate obtained from your finished product sample of Soco Chocolate ice cream sampled on June 9, 2022. We note that this product was manufactured under a product hold and test procedure, was not distributed, and was destroyed.
• (b)(4) L. monocytogenes isolates obtained from your environmental swabs on May 17, 2022
• (b)(4) L. monocytogenes isolates obtained from your environmental swabs on May 2, 2022
• (b)(4) L. monocytogenes isolates obtained from your environmental swabs collected on April 27, 2022
• (b)(4) L. monocytogenes isolates obtained from your finished product sample of KC Vanilla ice cream samples on February 9, 2023. We note that this product was manufactured under a product (b)(4) procedure, was not distributed, and was destroyed.
The WGS analysis determined that the above isolates represent (b)(4) of L. monocytogenes. The presence of the same strain of L. monocytogenes in your environment and in food products from your facility over multiple years is indicative of a resident pathogen.
We note that the above isolates also match (b)(4) isolates for yogurt mix bases that were manufactured by your facility and were supplied to and tested by a downstream customer in 2022. Most notably, this strain is genetically identical to (b)(4) clinical isolate from 2021, and (b)(4) clinical isolates from 2022, which indicates this strain has the capability of causing human illness. We first advised you of the importance these WGS results via a conference call on July 8, 2022. We provided subsequent notifications on August 12, 2022, September 2, 2022, October 12, 2022, March 10, 2023, September 18, 2023, and August 28, 2024, as additional sample or updated analysis information was received.
In addition, Vermont Agency of Agriculture, Food & Markets (VAAFM) obtained one (1) L. monocytogenes isolate from your finished product sample of Bart (b)(4)% Chocolate ice cream mix that you manufactured and sampled on July 5, 2024, for WGS analysis. VAAFM WGS for this isolate represent a strain not previously identified in your facility. We note that this product was manufactured under a product (b)(4) procedure, was not distributed, and was destroyed.
The detection of L. monocytogenes in finished product and the recurring presence of L. monocytogenes in your facility are significant in that they demonstrate your sanitation procedures have been inadequate to effectively control pathogens in your facility and 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 implementation of the hygienic practices necessary to control this pathogen. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive, and to apply controls or take corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and to prevent the organism from being re-established in such sites.
In your response to the inspectional findings of the most recent FDA inspection, including the findings of L. monocytogenes from an environmental swabs collected during the inspection, you provided corrective actions that describe retraining employees on proper dismantling and cleaning of connection pipes and fittings for the pasteurizer; adding hoses to the list of swab locations to be checked on a regular basis; eliminating the use of hoses to rinse off the filled product in packaging and converting to a (b)(4) bath system to rinse and sanitize the filled product in packaging; soaking hose nozzle in sanitizer in between use; and installing overhead hose reels pending funding.
Given the prior findings of L. monocytogenes in your finished products, repeat history of L. monocytogenes in your processing environment, including evidence of a resident strain, and most recent inspectional findings, we continue to be concerned about your ability to maintain a sanitary environment. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your environment or your RTE dairy products. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1) You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and contamination of food, as required by 21 CFR § 117.80(c)(2). Specifically:
a. On August 6, 2024, employees were observed handling soiled equipment and utensils during the process of making (b)(4)% vanilla ice cream base lot number (b)(4) in the pre-pasteurization area. Employees then proceeded to the post-pasteurization area without washing their hands and were seen touching various bags of ingredients used for RTE products, opening, and touching the tank containing finished ready-to-eat (b)(4)% vanilla ice cream base lot number (b)(4), touching clean carts, and handling hoses that contacted the floor.
b. On August 6, 2024, employees were observed in the pasteurized processing area using hoses equipped with pressure nozzles to spray off and clean equipment while also spraying areas of the damaged processing floor. Over-spray and mist from the hose used on equipment and the damaged floor were seen contacting the surface of the stainless-steel table that was being used to package (b)(4)% ice cream base lot number (b)(4).
c. On August 6th, 2024, an employee was observed on your single packaging line manually packaging RTE pasteurized (b)(4)% vanilla ice-cream base lot number (b)(4) via a dispensing pipe into (b)(4) lb. product bags. The open box containing exposed product packing bags was observed situated underneath an overhead metal pipe that was dripping condensate directly onto the box and the exterior of the product bags. The employee was observed retrieving empty product bags from the open box and proceeded to utilize the bags to package the aforementioned products, touching the cap/rim of the bags with a gloved hand that had come into contact with the bag's exterior, which had been in contact with the condensate.
d. On August 6, 2024, employees were observed routinely moving from the pre-pasteurized processing area to the pasteurized processing area without changing gloves or washing or sanitizing their hands.
e. On August 6, 2024, employees were observed walking into the foot baths containing dry powdered sanitizer (b)(4) before entering the production area. However, according to the sanitizer label directions for foot baths, the sanitizer must be dissolved in water to be effective.
f. During the current inspection, your facility's driveway was observed unpaved and there were areas covered in mud with pooling water. This driveway is located directly next to the entrance to the facility and approximately (b)(4) yards behind the facility, near an ongoing construction of the wastewater pit on the adjacent lot. The main entrance to the facility, utilized by employees, opens directly from this unpaved driveway. Furthermore, the changing room located about four feet from the main entrance lacked a clear separation between clean and soiled areas and was situated within (b)(4) feet of the entrance to the production room where ready-to-eat products are being produced and packaged.
g. On August 7, 2024, during the review of sanitation practices, the investigator noticed that the sanitation records did not accurately reflect the conditions observed in the production room. Furthermore, records such as the pre-operational sanitation inspection checklist and dry room cleaning and sanitation checklists were pre-filled and pre-signed copies by the agent in charge, and had been verified by the owner, rather than being original records, concurrently documented to reflect the actual conditions and activities at the time of occurrence.
Your firm’s corrective action response, dated September 9, 2024, describes some immediate corrective actions and some planned corrective actions as follows: you explained that you have instituted the use of low-pressure shower wands to reduce the risk of over spray; where applicable you have instituted the use of squeegees to assist in the reduction of spraying; you will continue to reduce the use of water in your post pasteurization area by installing a (b)(4) system ((b)(4)) prior to placement on a transport rack; you have future plans to install (b)(4) overhead hose reel ports in the post pasteurization area to keep hoses from coming into contact the floor pending food safety grant; you relocated the packaging away from the condensate and potential source of contamination; sterile packaging is now stored in a cleanable containment; you are planning to convert overhead pipes in the critical areas where condensate is a concern near the filling and packaging areas to condensate free piping pending a food safety grant; a load of crushed stone has been applied to the driveway and parking area; daily records are now complete, verified, and stored on file; and according to your response you have changed your practice to ensure that no records are pre-filled and that the records are reviewed and signed as the task is completed. We will verify the adequacy of these corrective actions during our next inspection.
2) You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, on July 12, 2022, FDA investigators observed the following conditions during the inspection:
a. Floor surfaces in the raw and pasteurized processing areas, specifically under pasteurizers number (b)(4) and under the firm’s mixing tank, were in poor condition, showing signs of cracking, with the surface marked by numerous areas of loose and deteriorated aggregate with rocks, pebbles, and other debris protruding from the surface.
b. Color-coded brushes designated for use on non-food contact surfaces (red) and food contact surfaces (blue) were found to be stored together in the pasteurized processing area. The brushes were stored in an inverted position, causing the handles and brushes to contact each other with liquid from both brushes observed dripping down to the handles.
Your September 9, 2024, response discussed that floors in areas noted above do need repair and that you are working on fixing the floor and plan to have it completed by late spring 2025, pending a food safety grant. In addition, your response explains that you have created and implemented new signage and training for designating a specific location for “blue” brushes (food contact) and “red” brushes (non-food contact) to store away from each other. We will verify the adequacy of these corrective actions during our next inspection.
3) Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4). Specifically:
a. Thick layers of ice build-up were observed on the pipe near the overhead refrigerator unit, as well as on the inside walls, floor, and entrance to the firm's freezer. Frozen condensate was noted on the surfaces of various finished products in the freezer. In addition, the freezer door did not function properly and had to be propped closed with a ladder, and the door molding on the right-side of the cooler door was observed to be cracked and split from the area of the handle to the bottom of the door.
b. Condensate droplets were observed dripping from overhead pipes located directly above covered vat pasteurizers (b)(4) where ready to eat pasteurized (b)(4)% vanilla ice cream base lot number (b)(4) was being processed.
Your September 9, 2024, response discussed that your firm would attempt to further reduce levels of accumulating condensate within the production area and that you are continuing to work on this item. Your response also addressed the frozen condensate in the freezer and explained that you are working on correcting this issue by removing an entry door that was in direct position to the production room and will repair the door seals to the freezer and cooler by November 1, 2024. We will verify the adequacy of your corrective actions during our next inspection.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility 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 or implement corrections to the violations cited in this letter. Failure to address this matter 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 fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documents. If you cannot complete all corrections within fifteen (15) days, state the reason for the delay and the time frame 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: Michael Dominick, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement, 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding this letter, you may contact Michael Dominick via email at Michael.Dominick@fda.hhs.gov. Please reference Case # 693165 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program