- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. James Orfitelli
- The Royal Ice Cream Company Inc.
27 Warren Street
Manchester, CT 06040-6534
- Issuing Office:
- Office of Human and Animal Food Operations East – Division 1
CMS # 630433
July 28, 2022
Dear Mr. Orfitelli:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) ice cream product manufacturing facility located at 27 Warren St., Manchester, CT 06040-6534, from January 19 through February 22, 2022. 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). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental 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 for samples collected from your production environment, we have determined that the RTE ice cream 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 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 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, the FDA investigators issued your facility a Form 483 (FDA-483), Inspectional Observations. We received your responses to the sample findings and Form 483 (FDA-483) on February 18, 2022, March 2, 2022, March 16, 2022, April 1, 2022, and April 12, 2022, describing corrective actions taken by your firm. 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 continuing concerns and to provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not identify and implement preventive controls adequate 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 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 or § 343(w)], to comply with 21 CFR § 117.135(a)(1).
Your facility manufactures ice cream products, RTE foods that are exposed to the environment prior to packaging, where they may be contaminated with environmental pathogens such as L. monocytogenes. The packaged ice cream products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
Your hazard analysis for ice cream products, dated March 8, 2020, covers all ice cream products manufactured at your facility and indicates that “pathogens” require a preventive control during processing at various steps such as “ (b)(4) / Packaging / Labelling”, “(b)(4)”, and “Assembly” and that “Preventive sanitation, Environmental monitoring programs, GMPs” are the preventive control measures applied at these steps where RTE food is exposed to the environment. However, as evidenced by the multiple and repeat findings of L. monocytogenes in your production environment, you did not identify and implement preventive controls adequate to ensure that you are significantly minimizing or preventing the hazard of the environmental pathogen L. monocytogenes.
In addition, your hazard analysis did not identify pathogens at your processing step of “(b)(4)” as requiring a preventive control because “Pathogens are unlikely to grow in the low temperature present in the freezer.” However, during the inspection, employees were observed transferring an RTE cookie dough sandwich sheet to the (b)(4), where the ice cream sheet was cut into 4 oz. bars and was exposed to the environment prior to packaging. L. monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE ice cream products, exposed to the environment at steps such as (b)(4), and L. monocytogenes does not require growth to present a hazard.
FDA’s inspection included the collection of environmental swabs on January 19, 2022, during production and found that two (2) of seventy-eight (78) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a filler head where RTE ice cream was being dispensed into pint-sized finished packages and one (1) swab was collected from the stainless-steel table where RTE ice cream sandwiches were being prepared. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in three (3) environmental swabs, including two (2) from areas adjacent to food-contact surfaces. Furthermore, in response to our 2022 environmental sample findings and your voluntary recall initiated in February 2022, the Massachusetts Department of Public Health (MDPH) collected retail finished product samples which confirmed L. monocytogenes in one (1) finished product sample of salted caramel ice cream.
Whole genome sequencing (WGS) was conducted on the following L. monocytogenes isolates obtained from the FDA environmental samples and the MDPH retail product sample, as follows:
- two (2) L. monocytogenes isolates obtained from FDA 2022 environmental sample 1167432;
- three (3) L. monocytogenes isolates obtained from FDA 2017 environmental sample 999084;
- one (1) finished product sample isolate of (b)(4) salted caramel ice cream manufactured by your firm on January 12, 2022 and sampled at retail by the MDPH.
Additionally, you voluntarily submitted isolates from your own testing from the environment, product samples, and raw material ingredient samples to be whole genome sequenced and analyzed by FDA. Based on the results of the WGS analysis, the six (6) isolates obtained by FDA and MDPH and your submitted isolates comprise three (3) different strains of L. monocytogenes. Two of these strains of are particular significance, specifically, one (1) strain is comprised of one (1) isolate derived from the environmental sample collected in 2022 and one (1) finished product sample isolate of (b)(4) salted caramel ice cream. This strain was genetically identical to an environmental swab, ingredient samples, and product samples collected by your facility in February 2022, March 2022, and April 2022, respectively; and genetically identical to one clinical isolate collected in 2021, which indicates this strain has the capability of causing human illness. A second strain, comprised of three (3) isolates derived from the environmental samples collected at your facility during our 2022 and 2017 inspections, were genetically identical, representing a single strain of L. monocytogenes. The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen or harborage site in your facility since 2017. We first advised you of the importance of these WGS results on March 4, 2022, and subsequently provided updates to the WGS analysis on the following dates: March 17, 2022, April 7, 2022, and June 30, 2022.
The detection of L. monocytogenes in finished products and reoccurring 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 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 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 areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites. Additionally, FDA has repeatedly detected Listeria innocua (L. innocua), a non-pathogenic Listeria species, in environmental samples collected from your firm during FDA inspections conducted in 2022, 2020, 2018, and 2017. The presence of Listeria species such as L. innocua suggests that conditions also are suitable for survival and/or growth of L. monocytogenes. Furthermore, in reviewing your facility’s environmental monitoring program, you have repeatedly found L. monocytogenes and Listeria spp. through your own testing from April 30, 2021, through January 19, 2022, from your RTE ice cream processing environment, including the (b)(4). During a regulatory meeting held with your firm on March 31, 2021, FDA communicated our concerns regarding your operations, including deficiencies within your written food safety plan and environmental monitoring program.
In response to current L. monocytogenes findings, you ceased production from February 8, 2022, to April 13, 2022, and conducted a voluntary recall of three lots of ice cream on February 1, 2022, which was subsequently expanded on February 11, 2022, to include all products within expiry. Additionally, you committed to performing corrective actions, which included conducting a root cause analysis to identify any potential niche or harborage areas to address any potential routes of contamination; performing an intensified cleaning and sanitizing of your production area; conducting intensified verification swabbing and finished product sampling; hiring a food safety consultant; and conducting a refresher training for employees. Although you provided a revised written hazard analysis on March 2, 2022, it is our understanding, after subsequent communication with your firm, that you are still working to further revise your written hazard analysis and other components of your food safety plan including your sanitation preventive controls procedures.
Given the history and current inspection 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 ice cream products. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
2. Your sanitation controls did not ensure that your 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, as required by 21 CFR § 117.135(c)(3).
Specifically, your “Sanitation Preventive Controls” dated 3/8/2020 stated, “Objective: To address 1) cleanliness of food contact surfaces and 2) prevention of allergen cross-contact and cross-contamination.” Your sanitation preventive control program lists procedures for cleaning and sanitizing of equipment; however, the procedures do not address the prevention of cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product, as required by 21 CFR § 117.135(c)(3)(ii). Furthermore, during the inspection on January 19, 2022, employee practices that could lead to cross-contamination of food-contact surfaces were observed at various steps during the manufacturing of ice cream products, as follows:
a. Employees handled exposed RTE ice cream products with their gloved hands, touching the top non-food contact surface of table #(b)(4), and then handled the food-contact surfaces of sheet pans without changing their gloves or washing and sanitizing their hands. FDA environmental sample INV1167432, swab 3, was collected from the top surface of table #(b)(4) and was found to be positive for L. monocytogenes.
b. Employees (b)(4) in-process RTE ice cream products at table #(b)(4) in the packaging area by (b)(4) via gloved hands. The employees then touched a trash barrel while placing (b)(4) into the barrel, and then either submerged their gloved hands in (b)(4) sanitizer or did not sanitize at all, before returning to their task of (b)(4) and handling exposed RTE ice cream products. The employees did not change their gloves or wash and sanitize their hands after contacting the trash barrel when disposing of the (b)(4).
c. An employee retrieved a mobile rack of in-process cookie dough sandwich sheets from the freezer by handling the non-food-contact surfaces of the rack and the freezer door handle with gloved hands. The employee did not change their gloves or wash and sanitize their hands before returning to their task of (b)(4) and handling exposed RTE ice cream products at table #(b)(4).
Your March 2 response indicated that you have updated your GMPs to prevent recontamination at all levels of handling and that you re-trained employees. As noted above, your responses also indicate that you are working with your food safety consultant to revise your sanitation preventive controls procedures. However, we have not received revised sanitation preventive controls procedures. We will verify the effectiveness of your corrective actions during our next inspection.
3. You did not establish and implement adequate written verification procedures for environmental monitoring, as required by 21 CFR § 117.165(b)(3).
Specifically, you did not collect your environmental swabs at the frequency identified within your “Environmental Monitoring Procedures” dated September 26, 2017. Your procedure stated, “(b)(4) swabs are selected and (b)(4),” and “(b)(4).” However, you did not collect swabs at this frequency or follow the criteria as described by your procedure. For example, you collected a total of (b)(4) swabs for the month on June 2, 2021, and all these swabs were collected from non-food-contact surfaces, two of which were noted as a retest from sample sites that were found positive for Listeria spp. on May 28, 2021. During the inspection, you indicated that swabs are routinely collected on a (b)(4), and this was confirmed by review of your analytical records.
Additionally, your environmental monitoring procedure did not identify the locations from which samples will be collected, as required by 21 CFR § 117.165(b)(3)(iii). During the inspection, you indicated that sampling sites are based on areas that are conducive to harborage and growth of Listeria species. While such sites are appropriate, they should be identified and listed in your procedures.
Your responses included a revised environmental monitoring procedure which identifies swabbing locations and supporting documentation indicating that you are continuing to perform corrective actions, including the collection of (b)(4) environmental samples from food-contact and non-food contact surfaces. You should continue to implement the necessary procedures, practices and processes to ensure foodborne pathogens do not contaminate your RTE food products. Your environmental monitoring procedure and record keeping will be critical to demonstrate the implementation of these corrective actions consistently over time. We will verify the adequacy of these corrective actions during our next inspection.
Supply-Chain Program (Subpart G)
1. Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required by 21 CFR § 117.410(c).
Specifically, your facility uses raw materials and ingredients including (b)(4) and inclusions (such as peanut butter cups and strawberry slices) which have been associated with pathogens such as L. monocytogenes and Salmonella. No additional lethality step is applied to any of your incoming raw materials and ingredients in manufacturing RTE ice cream. In your hazard analysis at your “Receiving of ingredients step,” you identified “pathogens” as a hazard requiring a preventive control, and the preventive control measure applied at this step is identified as “COA’s from supplier – Ingredient’s documentation checked.” Your “Supply-Chain Preventive Control (SCPC)” program, dated 3/8/2020, identified that, to approve suppliers and review them on an (b)(4), “each ingredient is assessed for the potential hazards (biological, chemical including radiological, physical, adulteration) as part of the preventive control process.” The SCPC identified supplier verification activities including “verify that each load of ingredients was produced by the approved supplier by checking the bill and manufacturer's name on the cases received,” “write the ingredients received, how many, and the ingredient codes,” and “document on receiving sheet.” Further, the SCPC stated, “Any product requiring supply chain control that is not from a verified supplier must be sent back or verified by testing that ingredients are ok.” However, L. monocytogenes and Salmonella in RTE food are hazards that for which there is a reasonable probability that exposure can result in serious adverse health consequences or death. Therefore, 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, as required by 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, as required by 21 CFR § 117.430(b)(1)(ii).
Your March 2 response included a copy of your supplier approval questionnaire, SOP for Receiving, and ingredient material receiving log, however, your provided documents did not address conducting onsite audits as part of your supplier verification activities. During the regulatory meeting held with your firm on March 31, 2021, you were made aware of the requirement to establish and implement a supply-chain program to adequately control hazards associated with incoming raw materials and ingredients. We continue to be concerned about your ability to establish and implement an adequate supply-chain program. We will verify the effectiveness of your corrective actions during our next inspection.
Current Good Manufacturing Practice (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 contamination of food, as required by 21 CFR § 117.80 (c)(2).
Specifically, on January 19, 2022, during the processing of ginger ice cream lot (b)(4), employees were observed using a high-pressure hose to rinse a stainless-steel pail and to spray the processing room floor, and overspray was aerosolizing immediately adjacent to uncovered flavor vats containing RTE (b)(4), uncovered RTE ingredients on the production table, and near the food-contact surfaces of the filler in the ice cream production area. FDA collected environmental sample (b)(4), swab (b)(4), from head of this filler and detected L. monocytogenes.
Your response indicates that you have taken corrective actions, including revising your GMP procedures and re-training of your employees. However, your response is unclear regarding whether you will continue the use of high-pressure hoses. We will verify the adequacy of your corrective actions during our next inspection.
2. Your equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not maintained to protect against contamination, as required by 21 CFR § 117.40(a)(1).
Specifically, on January 19, 2022, the (b)(4) (a food-contact surface) on your food tools (b)(4) were observed to be damaged with cracks and missing plastic. You collected environmental swabs on this date and detected L. innocua on the (b)(4) of this (b)(4) and L. monocytogenes from the body of the (b)(4).
Your response to the environmental sample results indicated that the “(b)(4)” were removed and replaced with new “(b)(4).” You further stated that the (b)(4) has been cleaned and sanitized and that you replaced other parts, including the start/stop buttons. We will verify the adequacy of these corrective actions during our next inspection.
3. You did not maintain your plant in a clean and sanitary condition, as required by 21 CFR § 117.35(a).
Specifically, on January 19, 2022:
a. Dripping condensate was observed on the overhead pipe in the corridor outside of the walk-in freezer. This is a high foot traffic area, and employees move from the corridor to the RTE ice cream production and packaging area.
b. The freezer condensate drain line exits the freezer through the wall into the corridor. Moisture was observed on the floor underneath this condensate line. This is a high foot traffic area, and employees move from the corridor into the RTE ice cream production and packaging area.
Your March 2 response indicates that you have taken corrective actions to eliminate the dripping condensation observed in your facility, including the installation of a trough and condensate collectors. We will verify the adequacy of these corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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. You should take prompt action to correct or implement corrections to 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 this office in writing within 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 documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Please send your reply to the U.S. Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488 or via email (preferred) to Scott.Loughan@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 or Scott.Loughan@fda.hhs.gov.
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1