FDA sent a warning letter to Velvet Ice Cream about Listeria Monocytogenes

The FDA has sent a warning letter (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/velvet-ice-cream-company-575444-05062019) to the Velvet Ice Cream Company of Utica, Ohio. The FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). In the environmental swabs collected, the FDA laboratory found the presence of Listeria monocytogenes. Nine environmental swabs were positive for Listeria. Whole genome sequencing of those swabs identified twenty-one isolates representing six different strains of Listeria monocytogenes. The same strain was found in seven isolates from the 2019 inspection, and eight collected during the 2018 inspection. This indicates that there is a resident pathogen or harborage site in the facility since 2018. Many other violations were also cited.