The epidemic strain of L. monocytogenes affected 28 people from 11 states.
Big Olaf Creamery LLC dba Big Olaf Sarasota, FL
The FDA has issued a notice to Big Olaf Creamery, a food firm in Florida due to a multistate outbreak of Listeria monocytogenes infections connected to ice cream. The epidemic strain of L. monocytogenes affected 28 people from 11 states, according to the Centers for Disease Control and Prevention. A pregnant patient suffered a miscarriage, and one patient passed away. On July 13, 2022, the company recalled all ice cream from the Big Olaf brand until June 30, 2022.
The FDA described an examination of Big Olaf Creamery LLC in Sarasota, FL, from July 19 to September 1, 2022, in a warning letter dated December 9, 2022. The FDA investigation determined that the company was not in compliance with FDA standards, leading to the issuance of an FDA Form 483.
The Food and Drug Administration sends warning letters to companies under its supervision as part of its enforcement activities. Warning letters are not issued until a corporation has been allowed months or years to correct the problems. Businesses have 15 days to reply to FDA warning letters. The letters are not posted for public view.
A multi-state listeriosis outbreak has been connected to Big Olaf ice cream.
This multi-state Listeria epidemic was examined by the CDC, FDA, Florida Department of Health, and FDACS. Whole genome sequencing of Listeria bacteria from the 28 ill persons revealed that the Listeria were genetically connected to one another, indicating that the people fell ill after consuming the same food. 14 of the sick people are Floridians, and 11 of them reported visiting the state prior to becoming ill. There were 27 hospitalizations with 7 illnesses affecting pregnant women or their newborns. There has been one fatality and one fetal loss attributed to listeriosis. All patients interviewed acknowledged eating ice cream, with 16 explicitly reporting eating Big Olaf ice cream or visiting Big Olaf Creamery locations in the month before their illnesses began;
Listeria infection symptoms can appear after up to 70 days. According to the warning letter, Big Olaf Creamery ice cream is the source of illnesses due to the presence of Listeria monocytogenes. Furthermore, between July 7 and 9, 2022, FDACS collected samples in which WGS analysis revealed that 10 environmental swab isolates and 20 ice cream product isolate matched clinical outbreak isolates from 2022 and 2021.
The firm contracted with a third-party laboratory to conduct environmental swabbing. And found Listeria monocytogenes in multiple pieces of equipment used to make ready-to-eat (RTE) ice creams. Four swabs of finished product ice cream buckets were also found to be positive for Listeria monocytogenes. The company’s sanitation procedures are insufficient to properly control pathogens in their facility and avoid food contamination.
Hazard Analysis and Risk-Based Preventive Controls
The company did not have a food safety plan prepared and implemented. The food safety plan must be prepared under the supervision of one or more preventive controls qualified individuals. It is necessary to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of the different RTE ice cream products manufactured, processed, and packed.
They failed to establish and implement preventive controls to ensure that any dangers requiring preventive control are considerably mitigated or prevented and that the RTE ice cream products manufactured, processed, packed, or retained by their facility are not adulterated or misbranded.
The food safety plan must include:
Preventive controls include process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall strategy, as relevant to the facility and the food. Preventive controls are subject to preventive control management components to maintain their effectiveness, they must validate that the preventive controls are sufficient to control the hazard in the facility’s food safety system.
The contamination with environmental pathogens such as listeria monocytogenes, Bacterial infections like salmonella, and allergens was not identified. Implementation of preventive measures is important. During the inspection, the company produced a draught SOP that comprised several operational procedures aimed at addressing food safety issues related to their production activities. But this procedure did not adequately describe how they will ensure control of dangers necessitating preventative controls in their ice cream goods.