The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) ice cream manufacturing facility, located at 2001 Cattlemen Rd Unit 123, Sarasota, Florida, from July 19 to September 01, 2022. The inspection was initiated as part of a joint investigation with the Florida Department of Health (FL DOH) and Florida Department of Agriculture & Consumer Services (FDACS) of a multistate outbreak of Listeria monocytogenes (L. monocytogenes) infections linked to ice cream supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), 28 ill people from 11 states were infected with the outbreak strain of L. monocytogenes. On July 13, 2022, your firm recalled all ice cream products, lots, and expiration dates of Big Olaf brand ice cream through June 30, 2022, because they had the potential of being contaminated with L. monocytogenes. CDC and FDA have determined, based upon the epidemiological data and Whole Genome Sequencing (WGS) matches between clinical and FDACS environmental and finished product samples that ice cream manufactured at this facility was the source of this multistate L. monocytogenes outbreak.
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).