FDA Found ‘Serious Violations’ At Big Olaf Ice Cream Facility: Letter

SARASOTA COUNTY, FL — While the U.S. Centers for Disease Control and Prevention declared the national listeria outbreak linked to Big Olaf Creamery’s ice cream over in November, the Food & Drug Administration sent the company a “warning letter” in December.

The CDC linked the outbreak, which left one person dead and 28 people ill, to the Sarasota County-based ice cream brand in June, the FDA said. During an investigation, 16 of the company’s 17 ice cream flavors that were tested had traces of the bacteria.

In its Dec. 9 letter to Big Olaf, the FDA recounted its joint investigation with the Florida Department of Health and the Florida Department of Agriculture & Consumer Services into the company’s ice cream manufacturing facility on Cattlemen Road. After the brand recalled all of its ice cream products, FDA and other agencies inspected the manufacturing facility from July 19 to Sept. 1.

“During the inspection of your facility, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117),” the FDA wrote in its letter to the company.”

Patch has reached out to Big Olaf Creamery and several local shops for comment about the letter. This article will be updated when they respond.

Following these inspections, the agency determined that ice cream products made at that facility are “adulterated” under the Federal Food, Drug and Cosmetic Act.

This means that the ice cream products “were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” the FDA wrote.

Once inspections were completed, the agency provided Big Olaf with a list of all the problems found at the facility.

The company hasn’t responded to the claims yet, the FDA wrote. “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.”

The agency asked Big Olaf to investigate its findings and to notify the FDA in writing of steps taken to address the violations listed or supporting information if they believe there are no issues at the facility.