In short summary, the company did not have a food safety plan in place, and along with that, apparently no controls for potential hazards. The company had not identified Listeria as a concern, and testing was only completed after it was the determined that the company as the source of the Listeria outbreak.
"After the product recall and in response to FDACS’s positive L. monocytogenes environmental and finished product samples and FDACS’s stop sale order ceasing all sale of ice cream products, your firm contracted with a third-party laboratory to conduct environmental swabbing (b)(4). Multiple pieces of equipment used to manufacture RTE ice cream products were reported positive for L. monocytogenes by your contract laboratory, including (b)(4). Additionally, four swabs of finished product ice cream buckets ((b)(4)) were reported positive for L. monocytogenes."https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/big-olaf-creamery-llc-dba-big-olaf-642758-12092022
Big Olaf Creamery LLC dba Big Olaf
MARCS-CMS 642758 — DECEMBER 09, 2022