The FDA sent a warning letter to Big Olaf Creamery after an inspection resulting from the infections linked to ice cream supplied by their facility. According to the CDC, 28 ill people, 27 hospitalized, from 11 states were infected with the outbreak strain of L. monocytogenes. On July 13, 2022, Big Olaf recalled all ice cream products, lots, and expiration dates of Big Olaf brand ice cream through June 30, 2022, because they could potentially be contaminated with L. monocytogenes. Based on the epidemiological data and WGS matches between clinical and environmental and finished product samples, the CDC and FDA determined 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. The FDA has determined that the RTE ice cream products manufactured in your facility are adulterated. Product samples and environmental samples produced isolates that matched the outbreak isolates. The FDA wrote that the presence of L. monocytogenes in the facility and products is significant because it demonstrates that your sanitation efforts are inadequate to effectively control pathogens. @ https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/big-olaf-creamery-llc-dba-big-olaf-642758-12092022#:~:text=On%20July%2013%2C%202022%2C%20your,being%20contaminated%20with%20L.%20monocytogenes
Big Olaf Creamery got a warning letter from FDA after the recall of their ice cream
Big Olaf Creamery LLC dba Big Olaf - 642758 - 12/09/2022
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
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