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WARNING LETTER

Ice Cream House LLC MARCS-CMS 686641 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Avigdor Klein, Co-Owner/Co-Chief Executive Officer
Recipient Title
Mr. David Klein, Co-Owner/Co-Chief Executive Officer
Ice Cream House LLC

2 Church Avenue
Brooklyn, NY 11218-3096
United States

Issuing Office:
Division of Human and Animal Food Operations East I

United States

WARNING LETTER
CMS #686641

09/24/2024

Dear Mr. Avigdor Klein and Mr. David Klein:

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) ice cream product manufacturing facility, located at 2 Church Avenue, Brooklyn, NY 11218-3096, from February 21 through March 26, 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, 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 analytical results revealing L. monocytogenes in 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 become contaminated with filth or 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 control 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 https://www.fda.gov.

Multistate Listeria monocytogenes Outbreak Linked to Ice Cream House
In July 2023, FDA, the Centers for Disease Control and Prevention (CDC), the New York State Department of Agriculture and Markets (NYSDAM), and the Pennsylvania Department of Agriculture (PDA) investigated a multistate outbreak of L. monocytogenes linked to ice cream products manufactured by your firm. The outbreak was associated with 2 cases in 2 states (New York and Pennsylvania) where both individuals were hospitalized and ultimately survived. Whole Genome Sequencing (WGS) performed on the clinical isolates from the cases in New York and Pennsylvania revealed that the clinical isolates matched the finished product samples that PDA collected from a private residence on July 27, 2023, and NYSDAM collected from your facility on August 4, 2023, and August 21, 2023. On August 30, 2023, your firm recalled all dairy and non-dairy ice cream products manufactured with the Ice Cream House logo. In response to this outbreak and the findings from an initial inspection of your firm conducted on September 6, 2023, through September 26, 2023, FDA conducted the current follow-up inspection. At the conclusion of the current inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. We received your written response to the sample findings and FDA-483 on April 16, 2024, describing corrective actions taken by your firm. 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 written response below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, 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). Specifically:

a. Your facility manufactures RTE ice cream products that are exposed to the environment prior to packaging and after any pathogen lethal treatment, where they may be contaminated with environmental pathogens such as L. monocytogenes. Your packaged ice cream does not receive any further lethal treatment or otherwise include a control measure that would significantly minimize the pathogen. In your food safety plan for soft serve ice cream, Version 1, dated September 1, 2023, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR 117.135(a)(1) and (c)(3), and as further discussed below.

FDA’s most recent inspection included the collection of environmental swabs on February 21, 2024, during production and found that 1 out of 110 swabs was confirmed positive for L. monocytogenes in the RTE processing area (sample #1234940). The positive swab was collected from the stainless-steel door and gasket of soft serve machine (b)(4). Prior to swabbing, pools of condensate were observed inside the machine after taking the equipment apart. Additionally, this was not the first time L. monocytogenes was found in environmental samples collected at your facility. On September 6, 2023, FDA detected L. monocytogenes in 3 environmental swabs from areas adjacent to food-contact surfaces (sample #1210746) during our initial inspection of your firm. Furthermore, in response to the previously mentioned outbreak of L. monocytogenes, PDA and the NYSDAM collected 8 finished product samples from your firm and a private residence, and 7 of those samples were confirmed positive for L. monocytogenes. The PDA samples were collected on July 27, 2023, and confirmed positive on August 7, 2023, while the NYSDAM samples were collected on August 4, 2023, and August 21, 2023, and confirmed positive on August 11, 2023, and August 29, 2023.

WGS was conducted on the L. monocytogenes isolates obtained from the FDA environmental samples and the NYSDAM and PDA finished product samples. WGS analysis revealed that the following isolates represent 1 strain, which matched the clinical isolates from the 2023 outbreak of L. monocytogenes linked to your firm’s soft serve ice cream:

  • 1 Vanilla/Chocolate “Soft Serve on the Go Dairy” cup obtained from a PDA finished product sample collected July 27, 2023;
  • 5 finished product samples of Vanilla/Chocolate “Soft Serve on the Go Dairy” cups collected by NYSDAM on August 4, 2023;
  • 1 mini cigar filled with soft serve ice cream obtained from the NYSDAM finished product sample collected August 21, 2023;
  • 3 environmental subsamples obtained from the FDA 2023 inspection (sample #1210746); and
  • 1 environmental subsample obtained from the most recent inspection (sample #1234940).

Sample #1210746 was collected on September 6, 2023, and sample #1234940 was collected on February 21, 2024. The presence of the same strain of L. monocytogenes over this time period after multiple cleaning and sanitation activities is indicative of a resident pathogen. We advised you of the importance of these WGS results via a conference call on March 12, 2024.

The prior detection of L. monocytogenes in your finished products and reoccurring presence of L. monocytogenes in your facility are significant in that they demonstrate your sanitation procedures 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 implementation of the hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. 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 take such corrective actions as are necessary to eradicate the organism.

In addition to the presence of L. monocytogenes, FDA detected Listeria innocua (L. innocua) in 1 swab from the pressure release valve below the soft serve release spout of soft serve machine (b)(4). The presence of Listeria species such as L. innocua suggests that conditions also are suitable for survival and/or growth of L. monocytogenes, which, as noted above, has been found in your facility. Furthermore, in reviewing your facility’s environmental monitoring program, you have repeatedly found L. monocytogenes and Listeria spp. through your own testing from August 2023 through December 2023 in your RTE ice cream processing environment (including drains, wheels and cabinets of soft serve machines, hoses from soft serve machines, and floors).

Your written response described retraining sanitation employees on proper dismantling and cleaning of soft serve machines; implementing a preventive maintenance plan to check machines regularly and to be able to identify any leaks or malfunctions in a timely manner to prevent contamination; and recleaning, resanitizing, and retesting according to your environmental monitoring plan.

Given the prior findings of L. monocytogenes in your finished products, repeat history of Listeria 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 ice cream products. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.

b. In your food safety plan for soft serve ice cream products, you established an Allergen Control at the pack and label step to address undeclared major food allergens, but you did not fully implement it. Your procedure states: “(b)(4) and (b)(4) the manager or a trained employee will check that the label matches product being packed.” In addition, your Label Verification Protocol Version 1 dated September 1, 2023, states that “[l]abel verification will be performed when: approving pre-printed labels or boxes, when printing labels in-house, and when applying labels to the products.” The protocol further states that “(b)(4) and (b)(4), the manager or trained employee will inspect the product label to ensure that the correct label is being applied to the product and that the following information is listed: Ingredient and allergen labeling based on the product recipe and ingredient specifications . . . .” However, according to your Packing Record on March 7, 2024, your employees had begun performing the pack and label step of the Vanilla/Chocolate soft serve, but label verification was not performed. Furthermore, prior to March 4, 2024, there was no Packing Record kept which documents label verification. More specifically, on (b)(4), you manufactured RTE Soft Serve Lite Natural Peanut Butter On-The-Go Cups which were distributed to Kleins Ice Cream on (b)(4). There was no record of label verification for this product.

Your written response indicated that label verification is done in 2 steps during (b)(4) and (b)(4); that label verification has been added to the packing records and employees have been retrained on packing procedures; and that existing labels are being reviewed according to the new system and the Lite peanut butter label was corrected. In addition, you provided the Packing Records for April 1 – April 5, 2024, and an updated Label Verification Protocol Version 3 dated April 9, 2024. We will verify the adequacy and implementation of your corrective actions during our next inspection.

Supply-Chain Program (21 CFR Part 117, Subpart G)

2. 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, you manufactured RTE Soft Serve Lite Natural Peanut Butter On-The-Go Cups on (b)(4) (lot (b)(4)), which was distributed to a customer on (b)(4). The ingredients that are incorporated into this ice cream product include: (b)(4). The hazard analysis in your food safety plan lists Supply Chain Controls at the receiving ambient step for peanut butter, chocolate, and confectionary products because of the association with a history of Salmonella contamination, and at the receiving frozen step for ice cream mix because the mix has a history of biological contamination. Your Supply Chain Protocol states that incoming goods which require supplier approval are accepted only after they are verified against the approved supplier register, and to be an approved supplier, “[s]uppliers which provide product for which a Supply Chain preventive control was identified must provide one of the following:

  • 3rd party Food Safety Audit
  • Certificate of Analysis
  • A copy of their Food Safety Plan for Ice Cream House to review
  • Letter of Continuing Guarantee
  • Supplier Questionnaire”

However, your Supply Chain Protocol does not specifically require review of (b)(4) onsite audit results to ensure control of vegetative bacterial pathogens (e.g., Salmonella and L. monocytogenes) in raw materials or other ingredients via your supply-chain program. Additionally, your facility does not provide a kill step to control vegetative bacterial pathogens in your ice cream products. L. monocytogenes and Salmonella are hazards that can cause serious adverse health consequences or death to humans or animals. 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 (see 21 CFR 117.430(b)). The audit must be conducted before using the raw materials or other ingredients from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).

Further, your firm did not follow your Supply Chain Protocol at the time of inspection. For example, you accepted (b)(4) dark roasted peanut butter as an ingredient, but there was no third-party audit, record of a qualified individual conducting an on-site audit of the supplier, or any other documentation provided as listed in the Supply Chain Protocol. According to your Supply Chain Approval Register dated September 1, 2023, this supplier was not listed as an approved supplier as required by your Supply Chain Protocol and 21 CFR 117.420(a). Under 21 CFR 117.420(a), the receiving facility must approve suppliers in accordance with the requirements of 21 CFR 117.410(d), and document that approval, before receiving raw materials and other ingredients received from those suppliers.

Your written response states: “The supply chain program was reviewed and updated according to the new FDA potential Hazards guide for each ingredient.” You also provided an updated Supplier Approval Register with a review date of March 19, 2024, for (b)(4). However, we are unable to fully evaluate this response due to a lack of supporting documentation, such as a revised supply-chain procedure.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

3. 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, our investigator observed the following during the inspection:

a. On February 21, 2024, a tarp was used to funnel leaks from the roof into a hose that emptied into a bucket next to the 3-compartment sink in the (b)(4) room. This roof leak had not been permanently repaired since the previous FDA inspection.

b. On February 29, 2024, cream was leaking from within soft serve machine (b)(4) and onto the floor, which could be a source of contamination.

c. On March 5, 2024, water tubing which led to the back of soft serve machine (b)(4) was leaking water onto the stainless-steel table where Chocolate Vanilla Soft Serve On-The-Go Cups were being filled. This could be another source of contamination.

Your written response indicated the roof has been permanently repaired, soft serve machines (b)(4) and (b)(4) were repaired, and the preventative maintenance plan will help prevent future malfunctions. We will verify the adequacy of these corrective actions and the implementation of your preventative maintenance plan during our next inspection.

This letter is not intended to be an all-inclusive statement of the 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. Failure to adequately 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 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: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.aveta@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email at Lillian.aveta@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

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