Big Olaf Creamery, LLC
Outcome
Big Olaf Creamery LLC recalled all ice cream flavors and lots in July 2022 and the Florida DACS issued a stop-production order after nine environmental samples tested positive for Listeria monocytogenes; the multistate outbreak caused 28 illnesses in 11 states, 27 hospitalizations, 1 death, and 1 fetal loss; FDA found no written food safety plan and no hazard analysis; a $4 million civil judgment including $1 million in punitive damages was awarded to the family of Mary Billman.
Details
Big Olaf Creamery, LLC — Listeria / No Food Safety Plan / $4M Civil Judgment (2022)
Outcome: Big Olaf Creamery recalled all ice cream in July 2022 and the Florida DACS halted production after nine environmental Listeria positives; the multistate outbreak caused 28 illnesses, 27 hospitalizations, 1 death (Mary Billman), and 1 fetal loss across 11 states; FDA's December 2022 warning letter found the creamery had no written food safety plan; a federal jury awarded the Billman family $4 million including $1 million in punitive damages based on a finding of conscious disregard for consumer safety.
Big Olaf Creamery, LLC operated an ice cream manufacturing facility in Sarasota, Florida producing ice cream sold at Florida tourist destinations and through retail channels. The outbreak investigation identified illness onset dates from January 24, 2021 through August 19, 2022 — the contamination persisted across roughly 18 months. CDC linked the outbreak strain of Listeria monocytogenes to Big Olaf ice cream through traceback and environmental testing; nine environmental samples collected from the Sarasota facility tested positive for the organism.
FDA inspection findings, documented in the December 9, 2022, warning letter, revealed the most fundamental possible food safety failures: the creamery had no written food safety plan and had never conducted a written hazard analysis as required under FSMA's Preventive Controls for Human Food rule (21 CFR Part 117). An additional investigative report found that employees did not have access to a handwashing sink during production operations — a basic sanitation requirement of the CGMP provisions. These findings indicate the facility operated with essentially no formal food safety infrastructure.
The Florida Department of Agriculture and Consumer Services issued a stop-production order and Big Olaf ceased production. As of November 2, 2022, CDC declared the outbreak over. In subsequent civil litigation, a federal judge determined that Big Olaf Creamery demonstrated conscious disregard for consumer safety and awarded the family of Mary Billman — a great-grandmother who died after consuming the contaminated ice cream — $4 million, including $1 million in punitive damages.
Primary Source: Big Olaf Creamery LLC - 642758 - 12/09/2022 | FDA
How Crucible Prevents This
The FDA inspection found that Big Olaf Creamery had no written food safety plan and no written hazard analysis — the two foundational FSMA requirements for any food facility. A Crucible-enforced session-gate that requires confirmation of an active, documented food safety plan before any production session would have flagged this facility as non-operational from a regulatory standpoint before the first ice cream scoop was made. Nine positive environmental swabs from a single inspection represent a facility with no active environmental monitoring program. Employees also had no accessible hand-washing sink during production — a basic sanitation failure that any daily compliance attestation would surface.
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