Listeria outbreak investigation details revealed in FDA warning letter to Big Olaf Creamery

As part of its enforcement efforts, the Food and Drug Administration is sending warning letters to organizations under its jurisdiction. Some letters are not published until weeks or months after they are sent. The business owner has 15 days to respond to the FDA warning letter. Warning letters are often not issued until the company has been given months or years to fix the problem.

Big Olaf Creamery LLC dba Big Olaf
sarasota, florida

A Florida food company has been notified by the FDA after a facility inspection caused by a multistate outbreak of Listeria monocytogenes. Infections associated with ice cream supplied to facilities of Big Olaf Creamery LLC.

According to the Centers for Disease Control and Prevention (CDC), 28 patients in 11 states were infected with the outbreak strain of Listeria monocytogenes. One patient died and one pregnant patient had a miscarriage. On July 13, 2022, the company recalled all ice cream products and Big Olaf brand ice cream through June 30, 2022 due to possible contamination with Listeria monocytogenes.

In its December 9, 2022 warning letter, the FDA described an inspection of Big Olaf Creamery LLC, located in Sarasota, Florida, from July 19 through September 1, 2022.

An FDA inspection revealed that the company was not in compliance with FDA regulations, resulting in the issuance of FDA Form 483. Some of the serious violations are:

Multistate Outbreak of Listeriosis Associated with Big Olaf Ice Cream
CDC, FDA, the Florida Department of Health, and the Florida Department of Agriculture and Consumer Services (FACS) investigated this multistate outbreak of Listeria. Monocytogenes infection associated with ice cream manufactured by Big Olaf Creamery. The investigation found that at least 28 patients in 11 states were infected with the outbreak strain of Listeria monocytogenes. Whole-genome sequencing was performed on Listeria monocytogenes from 28 sick people, showing that Listeria monocytogenes are genetically closely related to each other, suggesting that consuming the same food by sick people could lead to disease. Fourteen patients were Florida residents, and 11 were reported to have traveled to Florida before onset of illness. Of her 28 sick people with available information, 27 were hospitalized and 7 sick were pregnant or their newborns. Her 1 death and her 1 miscarriage attributed to listeriosis have been reported.

In the interviews, the sick people answered questions about the foods they ate and other exposures in the month before they became ill. The person specifically reported eating Big Olaf ice cream or eating at a location provided by the Big Olaf Creamery in the month before the illness began. In addition, she reported that one patient had eaten ice cream more than a month before the onset of symptoms. It can take up to 70 days for him to develop symptoms of listeria infection.

According to the warning letter, comprehensive epidemiological data, disease subcluster information, and food histories of travelers to Florida suggest that Big Olaf Creamery ice cream is the cause of disease in this outbreak of Listeria monocytogenes infection. It strongly indicates that

Additionally, on July 7 and 9, 2022, FACS collected samples (environmental swabs and finished packaged ice cream products from Big Olaf’s production environment). In this sample, 10 environmental swab isolates and 20 ice cream product isolates matched his 2022 clinical outbreak isolates and 2021 based on his WGS analysis.

Following a product recall, the company conducted environmental swabs in response to an FACS stop-sale order to stop the sale of all FACS-positive Listeria monocytogenes environmental and final product samples, as well as ice cream products. contracted with a third-party laboratory to (Edited)Multiple pieces of equipment used to make ready-to-eat (RTE) ice cream products have been reported to be Listeria monocytogenes positive by contract laboratories. (Edited)In addition, the finished ice cream bucket 4 swabs (Edited) Listeria monocytogenes positive was reported.

The presence of Listeria monocytogenes in the company’s facilities and its products demonstrates insufficient sanitation efforts to effectively control pathogens in facilities and prevent food contamination. is important in that Proper control of Listeria monocytogenes in food processing environments requires knowledge of the organism’s unique characteristics and implementation of the corresponding hygiene practices necessary to control this pathogen.

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

1. Failure to develop or have developed and implemented a food safety plan when required. Development of the food safety plan shall be overseen by one or more Preventive Controls Qualified Individuals (PCQIs), as appropriate. A company’s food safety plan must also include:

1) written hazard analysis;

2) written preventive controls;

3) a written supply chain program;

4) recall plan;

5) written procedures for monitoring the implementation of preventive controls;

6) written corrective action procedures;

7) written verification procedures;

However, the company did not have a food safety plan with the necessary elements.example (Edited) Determine whether various RTE ice cream products are manufactured, processed, packed, or held at your facility for hazards that require preventive controls.

In addition, preventative measures are taken to ensure that the hazards requiring preventive controls are substantially minimized or prevented and that RTE ice cream products manufactured, processed, packed, or held at the facility are not adulterated or fraudulently branded. Did not identify and implement controls. .

Preventive controls include process controls, food allergen controls, sanitation controls, supply chain controls and recall plans, depending on the facility and food. Given the nature of the preventive control and its role in the facility’s food safety system, the preventive control should include preventive control control components (monitoring, verification, and corrective action) as necessary to ensure the effectiveness of the preventive control. subject to You should also verify that the preventive control can adequately control the hazards, depending on the nature of the preventive control and its role in the facility’s food safety system. Specifically for RTE ice cream products:

a) The firm identifies and evaluates contamination with environmental pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. did not. Their facility manufactures RTE ice cream products that are exposed to the environment during processing.the ice cream machine (Edited). Also, (Edited)Packaged RTE ice cream products (Edited) It will greatly minimize pathogens. A knowledgeable person who manufactures/processes food will identify contamination with environmental pathogens as a hazard requiring preventive controls (ie, sanitation controls). Sanitation controls include procedures, practices, and processes for maintaining facilities in sanitary conditions sufficient to substantially minimize or prevent hazards, such as environmental pathogens and biological hazards, from employee handling. increase. Additionally, note that environmental monitoring is required if contamination of his RTE food with environmental pathogens is a hazard requiring preventive controls.

b) The Company did not identify and evaluate the allergen as a known or reasonably foreseeable hazard to determine whether the allergen is a hazard requiring a preventive control.their facility manufactures (Edited) A variety of RTE milk-based ice cream products with different flavors and inclusions. Some ingredients contain allergens (tree nuts (e.g. pecans), peanuts, cookie pieces (wheat), etc.). (Edited)In addition, inclusions are (Edited)These jars and scoops (Edited)Allergens are therefore known or reasonably foreseeable hazards. A person with knowledge of manufacturing/processing food in their situation identifies allergens as hazards requiring preventive controls. ) and to ensure that all food allergens requiring labeling are included on the label.

c) The Company did not identify and evaluate pathogens, such as Salmonella, as known or reasonably foreseeable risk factors for specific ingredients to determine whether a preventive control is required.their process does not apply (Edited) step into any of them (Edited)A knowledgeable person who manufactures/processes food will identify bacterial pathogens as hazards requiring preventive controls for these ingredients. Since these hazards are controlled at the supplier, the appropriate type of control is supply chain control. In addition, facilities that identify pathogenic or other hazardous raw materials or other ingredients that require supply chain applied controls must establish and implement a risk-based supply chain program for those raw materials or ingredients. Your supply chain program must include using approved suppliers and conducting supplier verification activities.

During the inspection, the company provided draft SOPs (standard operating procedures) containing various operating procedures aimed at addressing food safety hazards associated with manufacturing operations.It included a statement that their company would move forward (Edited)However, the draft procedure does not adequately describe how to ensure control of hazards requiring preventive controls in ice cream products.

for example:

  • The risk of contamination with environmental pathogens was not addressed in the draft procedure. (Edited)Also, their details were not included (Edited).
  • Draft procedure did not mention allergen hazards (Edited)It was also not included (Edited) Make sure the appropriate allergens are listed on the label of each product.
  • For pathogen hazards associated with ingredients such as nuts, the draft procedure was not (Edited)It also means that they (Edited).

You can read the full text of the warning here.

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