Dreyer’s Grand Ice Cream, Inc.

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September 29, 2026

WARNING LETTER

Re: CMS # 727644

Dear Ms. Kim Peddle Rguem:

The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 7301 District Blvd, Bakersfield, CA, 93313, between January 27 through February 20, 2026. During our inspection of your facility, an FDA investigator 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). Based on FDA's inspectional findings, we have determined that your frozen, ready-to-eat (RTE) ice cream cone products 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 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 website at www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. FDA received your emails, dated March 13, 2026 and April 13, 2026, which outlined corrective actions taken in response to the FDA-483. After reviewing the inspectional findings and your corrective actions, we are issuing this letter to advise you of FDA’s concerns.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)

1. You did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE ice cream cone products, as required by 21 CFR 117.130(a)(1). Specifically:

You provided a copy of a document that you stated was your hazard analysis for “Round Top Drumsticks, (b)(4)”, which considers the hazard of “Pathogen Contamination” such as “Listeria” and/or “Salmonella” at the following steps: “(b)(4)”. This document concludes that the hazard is not reasonably likely to occur, and it is not a significant hazard at each of the steps because your “sanitation prerequisite program controls this hazard by applying a validated cleaning procedure.” However, RTE products are exposed to the environment at these steps. Additionally, employees (b)(4) handle RTE products at the “(b)(4)” steps. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (e.g., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the 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 (see 21 CFR 117.135(c)(3)).

During the inspection, the FDA investigator reviewed your environmental monitoring records from 2021 through February 5, 2026, which revealed ongoing findings of Listeria monocytogenes (L. monocytogenes) and Listeria spp. from Zone (b)(4) sites throughout your production and auxiliary areas. Despite the continuous findings of L. monocytogenes in your environmental monitoring program, your hazard analysis did not identify contamination with environmental pathogens (e.g., L. monocytogenes) as a hazard requiring a preventive control. We note that while the overall percentage of L. monocytogenes findings have been reduced, as of February 5, 2026, you still had 19 positives for Listeria and 8 confirmed positives for L. monocytogenes in 2026. Taken together, the evidence shows that the hazard mitigation measures being implemented and documented do not fully address actual hazards present within your facility.

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 adequate controls, it can proliferate in food processing facilities and subsequently 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.

Furthermore, you stated that your sanitation prerequisite program includes but is not limited to documents such as: “Pathogen Monitoring Program Procedure”, “Bakersfield Sanitation Procedure”, line specific sanitation procedures, “Zoning and Good Manufacturing Practices Procedure”, “Hygienic Zoning Dry Sanitizer Map”, and “Production Listeria Treatment Form”. Section 5.1.3 of your document titled, “Pathogen Monitoring Program Procedure” lists corrective actions of: “If an area is having repeat positives, a team must be formed to investigate the issue...Investigative swabs, (b)(4) inspections, and data trending should be used in the investigation. Root cause and corrective actions will be documented using Lesson Learnt.” During the inspection, your Corporate Quality Manager stated to the FDA investigator that in actual practice, you investigate zone (b)(4) presumptive/confirmed positives by conducting a (b)(4). Contrary to your “Pathogen Monitoring Program Procedure”, your Corporate Quality Manager stated you do not document root cause investigations and other corrective actions for zone (b)(4) findings.

The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts have been inadequate to effectively control or prevent L. monocytogenes in your facility so as 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 corresponding hygienic practices necessary to control this pathogen. Your 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 cross-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 apply controls or 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.

Furthermore, your document titled, “Zoning and Good Manufacturing Practices Procedure” states “Personal Hygiene Practices”, including hand washing and glove use, “are mandatory and need to be followed by all personnel entering the Bakersfield Factory”. Among other things, Section 3.17.9 specifies that employees must wash their hands "When hands become soiled and/or are in contact with unclean utensils or surfaces...When working in a product contact or open product environment hands must be washed and/or sanitized after touching anything unsanitary (pallets, floors, waste/trash containers, unsanitary equipment, etc.)”. Section 3.18 states “Employees to wear disposable (b)(4) gloves when handling unwrapped finished product or touching food contact surfaces except for lines with handwash sinks where frequent hand washing has replace[d] use of (b)(4) gloves for some tasks...Gloves must be changed (b)(4)...Heavy duty reusable gloves are not permitted for direct product handling...” However, the FDA investigator observed employees deviating from the procedure, as detailed below:

i. On January 28, 2026, during the manufacturing of RTE (b)(4) Minis Chocolate Chip Vanilla Sandwich, 12 ct., BEST BY 31 OCT 2026 06-30 (b)(4), an employee on Line (b)(4) was wearing heavy duty reusable gloves while repeatedly alternating between touching non-food-contact surfaces while opening and breaking down cardboard boxes previously stacked on a pallet, and touching trash bin liners that come in contact with discarded trash; food-contact surfaces (e.g., (b)(4)); and RTE food (e.g., cookies to be used in sandwiches). Employees repeated this process without washing/sanitizing their hands or changing to disposable gloves, contrary to their “Zoning and Good Manufacturing Practices Procedure”.

ii. On January 28, 2026, during the manufacturing of RTE (b)(4), 24 ct., BEST BY 31 JAN 2027 06-30 (b)(4), an employee on Line (b)(4) was wearing (b)(4) gloves while repeatedly alternating between touching non-food-contact surfaces while opening and breaking down cardboard boxes previously stacked on a pallet, wiping their hands on their uniform after removing jammed cookies on the line, and touching trash bin liners that come in contact with discarded trash; food-contact surfaces (e.g., clear plastic sleeves holding cookies); and RTE food (e.g., cookies to be used in sandwiches) without changing their gloves or washing/ sanitizing their hands, contrary to their “Zoning and Good Manufacturing Practices Procedure”.

iii. On February 13, 2026, during the manufacturing of RTE (b)(4), Vanilla Fudge, Vanilla Caramel, and Vanilla, 16ct, containing chopped peanuts, BEST BY 28 FEB 2027 06-30 (b)(4), an employee on Line (b)(4) repeatedly alternated between touching non-food-contact surfaces (e.g., the interior surface of a lined trash bin while discarding empty peanut packaging, the bottom surface of (b)(4) bins covered in brown residues, and the handle on a (b)(4) lid); food-contact surfaces (e.g., inside the (b)(4) bag, and inside the (b)(4) bins containing the peanuts), and RTE food (e.g., chopped peanuts) without changing their gloves or washing/sanitizing their hands, contrary to their “Zoning and Good Manufacturing Practices Procedure”.

iv. On February 11, 2026 during the manufacturing of RTE (b)(4) Mini Fruit Pops Cherry, Tangerine, Grape, 12ct, BEST BY 31 MAY 2027 06-3 (b)(4), an employee on Line (b)(4) repeatedly used their bare hands to touch multiple non-food-contact surfaces (e.g., cardboard boxes previously stacked on a pallet, stair railings, the interior surface of a lined trash bin, trash on the floor, the bottom surface of the yellow wet waste bin used as a stool for sitting) before handling food-contact surfaces (e.g., (b)(4) used to individually wrap and seal frozen fruit pops) during film roll changes, without washing/sanitizing their hands or wearing gloves, contrary to their “Zoning and Good Manufacturing Practices Procedure”.

Your FDA-483 responses dated March 13, 2026 and April 13, 2026, demonstrate significant effort to address the identified deficiencies. For example, your stated corrective actions include, but are not limited to the following:

• You implemented a new Pathogen Investigation Form to serve as the facility's corrective and preventive action (CAPA) form for all Listeria positives regardless of zone. The form covers background information gathering, investigative swabbing, corrective actions, effectiveness verification, root cause identification, preventive action assignment, and product impact evaluation.
• You conducted duplicate swabbing and identified three presumptive positive sites, including the site of the FDA sample that tested positive for Listeria innocua, the (b)(4) of the (b)(4) on Line (b)(4). You submitted root cause investigation summaries as well as corrective and preventive action summaries.
• For the past three years, you have verified employee compliance with handwashing and glove requirements through (b)(4) measuring Enterobacteriaceae levels, with operator coaching provided as needed. This swabbing has identified no bacteria on gloves in 2026.
• You conducted a (b)(4) Lesson on proper hand sanitizer use when working with food contact equipment, packaging, or ingredients, and installed additional hand sanitizer stations on all lines to facilitate more frequent use.
• You instructed (b)(4) quality technicians to pay particular attention to glove use and document instances of improper glove use.
• You identified additional opportunities for operators to sanitize hands and gloves between tasks involving non-food contact surfaces and provided additional hand sanitizer stations on the line.
• You reallocated operator responsibilities so that (b)(4) (food contact surfaces). The operator handling food contact surfaces is required to sanitize gloves whenever contact with a non-food contact surface occurs.
• You revised the (b)(4) procedure to require glove sanitization before touching rolls, specify that only the edges of the wrap or its core be touched when possible, and prohibit touching surrounding surfaces during roll installation.
• You revised the peanut rework ingredient addition procedure to eliminate direct operator contact with peanut ingredients by requiring the use of a stainless-steel scoop for ingredient loading.

However, your response focuses primarily on immediate corrective actions and does not adequately address the underlying conditions evidenced by years of positive Listeria findings in the facility's environment. For example, among other things, you did not indicate whether a comprehensive facility-wide deep clean or environmental remediation was conducted. You did not address why previous corrective actions failed to prevent recurrence of Listeria. Additionally, you did not indicate whether you reanalyzed your hazard analysis.

Furthermore, your Pathogen Monitoring Program Procedure, dated April 1, 2026, states, “samples are collected based on the sampling plan and schedule.” However, your response did not include rationale for how the sampling plan and schedule were developed; as such, we are unable to assess whether they are commensurate with the volume of products produced at your facility.

Lastly, you stated you have verified employee compliance with handwashing and glove requirements through glove swabs measuring Enterobacteriaceae levels for the past three (3) years. We note that Enterobacteriaceae testing does not detect Listeria spp. As such, this testing does not demonstrate that employee handling practices are effectively preventing Listeria contamination at your facility. We will verify the adequacy of your corrective actions during the follow-up inspection.

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

1. You did not ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conformed to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b).

Specifically, your Corporate Quality Manager stated to the FDA investigator that (b)(4) sanitizer are used to control pathogen contamination within the production area. However, on January 27, 2026, February 5, 2026, February 10, 2026, and February 12, 2026, the FDA investigator did not observe the use of (b)(4) sanitizer. Furthermore, employees were not utilizing available (b)(4). For example, the (b)(4) in the wet waste area was placed to the side, out of the traffic path, and was torn on one side, causing sanitizer to drain out. Employees were observed exiting the (b)(4) area and entering the (b)(4) area while pulling (b)(4). Additionally, there were no (b)(4) placed (b)(4), and on February 10, 2026, employees were observed pushing wheeled carts and pulling (b)(4). On February 10, 2026, (b)(4) were placed next to the exit doors; however, employees were not stepping into them prior to entering production area. Lastly, a large black plastic sheet was observed partially obstructing the (b)(4) near the (b)(4) door.

Your FDA-483 responses state, among other things, that you requested a third-party chemical provider assessment of your current hygienic barriers to identify appropriate sanitizers and concentrations and implemented the recommendations throughout the facility. You implemented a new Sanitation Team Daily Checklist requiring sanitation personnel to document monitoring of hygienic barriers and note any corrections needed. You replaced the foot bath in the (b)(4) Area with a (b)(4) and added a (b)(4) at the (b)(4) door in that area to ensure proper hygienic barriers remain in place in the event of a door failure. You coached relevant operators on the purpose and proper application of dry sanitizer, which is currently being applied throughout the facility in designated areas. You consulted a third-party chemical provider and determined that (b)(4) and (b)(4) not needed given that these rooms are of the same hygiene level but confirmed that (b)(4) are needed (b)(4) of the facility. We will verify the adequacy of your corrective actions during the follow-up inspection.

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 applicable FDA regulations.

This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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.

Your written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. If you have any questions regarding this letter, you may contact Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. Please reference CMS # 727644 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program