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WARNING LETTER

December 9, 2022

23-HAFE4-WL-02/CMS No. 642758

Dear Mr. Peachey:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) ice cream manufacturing facility, located at 2001 Cattlemen Rd Unit 123, Sarasota, Florida, from July 19 to September 01, 2022. The inspection was initiated as part of a joint investigation with the Florida Department of Health (FL DOH) and Florida Department of Agriculture & Consumer Services (FDACS) of a multistate outbreak of Listeria monocytogenes (L. monocytogenes) infections linked to ice cream supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), 28 ill people from 11 states were infected with the outbreak strain of L. monocytogenes. On July 13, 2022, your firm recalled all ice cream products, lots, and expiration dates of Big Olaf brand ice cream through June 30, 2022, because they had the potential of being contaminated with L. monocytogenes. CDC and FDA have determined, based upon the epidemiological data and Whole Genome Sequencing (WGS) matches between clinical and FDACS environmental and finished product samples that ice cream manufactured at this facility was the source of this multistate L. monocytogenes outbreak.

During the inspection of your facility, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on our inspectional findings, 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 contaminated with filth or 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, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility. To date, we have not received a written response from you describing the corrective actions you have taken or plan to take at your facility.

Multistate Outbreak of Listeriosis Linked to Big Olaf Ice Cream

CDC, FDA, FL DOH, and FDACS investigated this multistate outbreak of L. monocytogenes infections linked to ice cream produced by Big Olaf Creamery. This investigation included 28 ill people in 11 states who were infected with the outbreak strain of L. monocytogenes. WGS was performed on Listeria bacteria from the 28 ill people and showed that the Listeria were closely related genetically to one another indicating that ill people became sick from consuming the same food. Fourteen ill people are residents of Florida, and eleven reported traveling to Florida prior to illness onset. Among 28 ill people with available information, 27 (96%) were hospitalized, and seven illnesses were in pregnant people or their newborns. One death and one fetal loss attributable to listeriosis have been reported.

In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of 23 people interviewed, all (100%) reported eating ice cream and 16 (70%) specifically reported eating Big Olaf ice cream or at locations supplied by Big Olaf Creamery in the month before their illnesses started; one additional ill person reported eating ice cream more than one month prior to illness onset. This proportion is significantly higher compared to sporadic listeriosis cases not associated with an outbreak from the same states as ill people in this outbreak (p-value<0.0003).

The overall epidemiologic data, illness sub-cluster information, and food histories of travelers to Florida strongly indicate that Big Olaf Creamery ice cream is the source of illnesses in this outbreak of L. monocytogenes infections.

Furthermore, on July 7 and 9, 2022, FDACS collected samples (environmental swabs of your production environment and finished, packaged ice cream product), in which 10 environmental swab isolates and 20 ice cream product isolates match the clinical outbreak isolates from 2022 and 2021 based on WGS analysis.

After the product recall and in response to FDACS’s positive L. monocytogenes environmental and finished product samples and FDACS’s stop sale order ceasing all sale of ice cream products, your firm contracted with a third-party laboratory to conduct environmental swabbing (b)(4). Multiple pieces of equipment used to manufacture RTE ice cream products were reported positive for L. monocytogenes by your contract laboratory, including (b)(4). Additionally, four swabs of finished product ice cream buckets ((b)(4)) were reported positive for L. monocytogenes.

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, 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.

The presence of L. monocytogenes in your facility and your products is significant in that it demonstrates your sanitation efforts 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 implementing the corresponding hygienic practices necessary to control this pathogen.

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

1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:

1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).

However, you did not have a food safety plan with any of the required elements. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of the (b)(4) different RTE ice cream products manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the RTE ice cream products manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically, for your RTE ice cream products:

a) You did not identify and evaluate contamination with environmental pathogens, such as L. monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your facility manufactures RTE ice cream products which are exposed to the environment during processing. The ice cream machine is (b)(4). Also, (b)(4). The packaged RTE ice cream products (b)(4) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., 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)). In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)).

b) You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures (b)(4) different RTE milk-based ice cream products, with a variety of flavors and inclusions. Some inclusions contain allergens (such as tree nuts (e.g., pecans), peanuts, and cookie pieces (wheat)). (b)(4). In addition, inclusions are (b)(4). These bins and scoops (b)(4). Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be declared are included on the label (see 21 CFR § 117.135(c)(2)).

c) You did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard in certain ingredients to determine whether they require a preventive control. Your process does not apply a (b)(4) step to any of your (b)(4). A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control in these ingredients, and because these hazards are controlled at your suppliers, the appropriate type of control is a supply-chain control. Further, a facility that identifies raw materials and other ingredients with hazards such as bacterial pathogens that require a supply-chain-applied control must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410).

We note that you do not (b)(4). In addition, you do not (b)(4). During the inspection, you stated that Certificates of Analysis (COAs) are occasionally received from suppliers. The FDA Investigator reviewed a COA from a supplier, but you were unaware what this document represented. Note that Salmonella in ingredients such as RTE peanuts and tree nuts is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity when the supplier controls the hazard 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 material or other ingredient from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).

During the inspection, your firm provided a draft SOP that included various operational procedures intended to address food safety hazards associated with your manufacturing operations. It included a statement that going forward your firm will (b)(4). However, this draft procedure did not fully explain how you will ensure control of hazards requiring a preventive control in your ice cream products.
For example:

• Regarding the hazard of contamination with environmental pathogens, the draft procedure did not describe (b)(4). Also, it did not include details of your (b)(4) (as specified in 21 CFR 117.165(b)(3)).
• Regarding the hazard of allergens, the draft procedure did not describe (b)(4). Also, it did not include a (b)(4) to ensure the appropriate allergens are declared on labels for each product.
• Regarding the hazard of pathogens associated with ingredients such as nuts, the draft procedure did not (b)(4). Also, it did not indicate that you (b)(4).

Further, to date, you have not submitted a response to the Form FDA 483, you have not indicated that you are implementing your draft procedure, or and you have not provided evidence that you have conducted a hazard analysis and developed a comprehensive food safety plan with the required elements.

The violations in this letter are not intended to be an all-inclusive list 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 identified above 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. You should take prompt action to address 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 FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these 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 directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to the email address: orahafeast4firmresponses@fda.hhs.gov. Please ensure your firm name, Firm Establishment Identifier (FEI), and establishment address are included in the correspondence. If you have any questions regarding this letter, please contact, Ms. Beira Montalvo, Compliance Officer, at (561) 416-1065, Ext. 1108 or via email at Beira.Montalvo@fda.hhs.gov.

Sincerely yours,
/S/

Ramon A. Hernandez
District Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food Operations,
East Division IV