Velvet Ice Cream Company Inc.’s ice cream manufacturing facility in Utica, OH, was inspected by the FDA from Jan. 23 to Feb. 14 and the results were not good. Lab tests showed the plant was harboring the pathogen Listeria monocytogenes.

Environmental samples collected at the facility during this year’s inspection returned positive results for the same strain of the potentially deadly pathogen inspectors found during an FDA inspection in 2018.

“During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation,” FDA’s East Division Director said in a warning letter to the ice cream manufacturer.

based on the FDA’s inspectional findings, and the analytical results for the environmental samples, the FDA determined that the ice cream manufactured in the firm’s facility is adulterated, in that it was prepared, packed or held under insanitary conditions wherby it may have been rendered injurious to health.

The following were among Velvet Ice Cream Company Inc.’s violations of the regulations for Hazard Analysis and Risk-based Preventive Controls:

Firm’s are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded; “In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes.”

Nine environmental swabs collected by FDA during the most recent inspection were positive for L. monocytogenes; “Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in nine swabs within your facility and environmental swabs collected during our 2017 inspection revealed L. monocytogenesin three swabs within your facility.”

Whole genome sequencing (WGS) of isolates detected in the FDA environmental samples identified twenty-one isolates representing six different strains of L. monocytogenes. The same strain of L. monocytogenes was identified in seven isolates from environmental samples collected during the 2019 inspection and eight isolates collected during the 2018 inspection.

The FDA advised the firm of those WGS results via a conference call on February 27, 2019, and the presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen or harborage site in their facility since 2018.

Additionally, “that strain of L. monocytogenes was genetically identical to one clinical isolate collected in 2018, which indicates this strain has the capability of causing human illness.”

These findings demonstrate that the firm’s sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in their facility. once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product; “It is essential to identify the areas of the food processing plant wher this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”

The FDA acknowledged that the firm has committed to performing corrective actions in written responses which we received by the FDA on February 7, February 27, March 16, and April 24, 2019; “In your written responses, you indicate that you have conducted a root cause analysis to identify the source of our findings, cleaned and sanitized your production environment, conducted environmental swabbing to verify the effectiveness of your cleaning, and completed other activities to address the problems.” The FDA noted that the firm’s effectiveness of their corrective actions will be “verified” during the FDA’s next inspection.

The FDA also noted the following cGMP violations:

The firm did not clean their non-food contact surfaces in a manner, and as frequently as necessary, to protect against contamination; “Specifically, on January 30, 2019, our investigators observed an employee using a high-pressure hose to spray the floor with water while performing sanitation operations. They observed overspray from the floor onto equipment reported as having been cleaned and from the floor onto unopened buckets of ingredients that were going to be used to produce ice cream the next day.”

The firm’s corrective action indicates that they will lower the water pressure and retrain their employees on the use of water and clean up procedures; “We will verify the adequacy of this corrective action during our next inspection.”

The plant was not constructed and designed to facilitate maintenance and sanitary operations; “Specifically, the design of the production floor does not allow for the proper drainage of water. Water used in the cleaning of equipment pools in various locations throughout the production area of your facility, which can provide harborage areas for pathogenic bacteria such as Listeria.”

The firm’s corrective actions indicate that they have re-sloped their floor to address the observations of pooling water. The FDA noted that they will verify the adequacy of this corrective action during their next inspection.

FDA investigators added that the above is not intended to be an “all-inclusive list of violations” at the firm’s facility or in connection with their RTE ice cream products, and that the firm is responsible for ensuring that their facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws.

“You should take prompt action to correct the violations noted in this letter,” the FDA advised, “Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.”

Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

By Kelsey M. Mackin