FDA WARNING_LETTER - Big Olaf Creamery LLC dba Big Olaf - September 01, 2022

The FDA issued a Warning Letter to Big Olaf Creamery following an inspection from July 19 to September 1, 2022, at their Sarasota, Florida, ready-to-eat (RTE) ice cream manufacturing facility. This inspection was part of a joint investigation with the Florida Department of Health and Florida Department of Agriculture & Consumer Services into a multistate *Listeria monocytogenes* outbreak linked to their ice cream. The CDC reported 28 illnesses across 11 states, with one death and one fetal loss. Epidemiological data and Whole Genome Sequencing confirmed Big Olaf ice cream as the outbreak source, with environmental and finished product samples matching clinical isolates.

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (21 CFR Part 117), rendering their RTE ice cream products adulterated. Key violations include the firm's failure to prepare and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). Specifically, the firm did not conduct a hazard analysis to identify and evaluate known or foreseeable hazards like environmental pathogens (*L. monocytogenes*), allergens, and bacterial pathogens (e.g., *Salmonella*) in certain ingredients. Consequently, they failed to implement required preventive controls, such as sanitation controls, food allergen controls, and a supply-chain program with proper supplier verification activities (