The operators of Big Olaf Creamery LLC did not have a viable food safety plan, according to a Dec. 9 warning letter sent by the Food and Drug Administration to David S. Peachey, co-owner and president. The warning letter was made public Dec. 27.

The ice cream maker was linked this past July to a Listeria outbreak that caused the death of one consumer and sickened 28 across 11 states, according to the Centers for Disease Control and Prevention.

“… You did not have a food safety plan with any of the required elements,” the FDA letter said. “For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of the different RTE (ready-to-eat) ice cream products manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control.

“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…”

The FDA inspection, which was conducted in conjunction with the Florida Department of Health and Florida Department of Agriculture and Consumer Services, occurred between July 19 to Sept. 1, 2022.

“At the conclusion of the inspection, FDA issued a Form FDA 483, inspectional observations, listing the deviations found at your facility,” the Dec. 9 letter said. “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.”

Big Olaf Creamery was founded in 1982. The company supplies ice cream to its own licensed shops as well as other shops in Florida, according to the company’s website.