There still are food processors out there without food safety plans! That was one of the charges in a December FDA warning letter to a Florida ice cream manufacturer that was the source of a listeria outbreak that sickened 28 people and may be the cause of one death and one miscarriage.
Big Olaf Creamery of Sarasota, Fla., in July recalled all flavors and all lots of Big Olaf brand ice cream products because of apparent Listeria monocytogenes contamination. The product was sold at Big Olaf retailers in Florida as well as to consumers in restaurants and senior homes, and one location in Fredericksburg, Ohio, according to the FDA.
Eventually, 28 people in 11 states were infected with the outbreak strain of L. monocytogenes. 27 of them were hospitalized, and seven illnesses were in pregnant people or their newborns. One death and one fetal loss attributable to listeriosis were reported, according to the FDA.
FDA inspected the facility from July 19 to Sept. 1 and collected environmental swabs of the production environment and finished, packaged ice cream product. Samples from the plant matched the strain of listeria in the outbreak.
In the December letter, the agency “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation” and termed the ice cream made there as “adulterated.” Products “were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.”
In addition, the agency cited the “failure of the owner, operator, or agent in charge … to comply with the preventive controls provisions of the CGMP & PC rule.” David Peachey was named as co-owner and president. One of the findings noted, “You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1).”
As of the FDA’s Dec. 9 warning letter and our look on the FDA website today (Jan. 4), there had been no response from the company.