FDA lifts suspension, reinstating facility registration for Working Cow Homemade, Inc.
February 15, 2019
- In October 2018, the FDA suspended the food facility registration for Working Cow Homemade, Inc. and subsequently the firm voluntarily ceased operations.
- In the months following the suspension, Working Cow Homemade, Inc. submitted a proposed shift in business to become a warehouse distributor of ice cream products. The company will not resume ice cream manufacturing operations, but instead will store and distribute product sourced from third party manufacturers.
- Given the proposed changes and commitments by the firm, along with FDA site inspection and verification, the FDA has lifted the suspension, reinstating the facility registration for Working Cow Homemade, Inc.
- On October 19, 2018, the FDA used the authority granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Working Cow Homemade, Inc. of St. Petersburg, FL, because products manufactured in this facility may cause serious adverse health consequences.
- Ice cream manufactured by Working Cow Homemade, Inc. has been linked to three cases of listeriosis in Florida. Working Cow Homemade, Inc. primarily distributes product in Florida, and has voluntarily ceased their operations.
- The suspension of the firm’s registration is an administrative action that allows the FDA to ensure that the firm has implemented necessary corrective actions to protect public health before resuming operations.
- The FDA’s decision to suspend the registration of Working Cow Homemade, Inc. was prompted by the three cases of and findings from the FDA’s 2017 and 2018 inspections of Working Cow Homemade, Inc., which identified insanitary conditions that could lead to contamination with Listeria monocytogenes (L. mono) in finished products. The FDA worked together with the Centers for Disease Control and Prevention, the Florida Department of Health, and the Florida Department of Agriculture & Consumer Services.
- All ice cream products manufactured by Working Cow Homemade, Inc., from August 29, 2017 – October 11, 2018 have been recalled. Consumers should not eat, retailers should not sell, and institutions should not serve these products. Consumers, retailers, and institutions should discard these products.
- No food can leave the Working Cow Homemade, Inc. facility for sale or distribution while the food facility registration is suspended.
What is the problem and what is being done about it?
The FDA worked together with the Centers for Disease Control and Prevention, the Florida Department of Health, and the Florida Department of Agriculture & Consumer Services. On October 19, 2018, the FDA issued a Suspension of Food Facility Registration Order to Working Cow Homemade, Inc. of St. Petersburg, FL after an inspection revealed insanitary conditions at and evidence of clinical cases of listeriosis linked to ice cream produced by the firm that could affect the safety of finished products. The FDA inspected the facility from August 29 to September 1, 2017. During this inspection, the FDA collected environmental samples from the facility, which resulted in a recall and commitments by the firm to implement corrective actions. In September 2018, the Centers for Disease Control and Prevention contacted the Florida Department of Health after finding that the pathogen analyses of three clinical cases (two in 2013, one in 2018), of listeriosis were highly related to the pathogen analyses of 2017 environmental samples taken by the FDA at the production facility.
Based on this information, the FDA conducted a follow-up inspection of the facility from September 25 through October 15, 2018. Whole Genome Sequencing (WGS) results for positive samples were submitted to the Pathogen Detection portal at the NIH National Center for Biotechnology Information. Results from Pathogen Detection identified potential links to prior cases of listeriosis. Further analysis conducted by the FDA confirmed that the L. mono isolates collected from three ill patients were genetically identical to the L. mono isolates taken from environmental samples in the Working Cow facility in 2017 and 2018.
At the close of the 2018 inspection, the FDA provided Working Cow Homemade, Inc. with several inspectional observations (Form FDA 483), noting sanitation and production issues. In addition, the firm did not provide evidence of implementing corrective actions the firm committed to in response to the 2017 inspection and did not have information or documentation for the firm’s food safety plan including developing written sanitation practices, required by FSMA. Based on these observations, ready-to-eat (RTE) ice cream products manufactured, processed, packed, received or held at the Working Cow facility have a reasonable probability of causing serious adverse health consequences or death. The risk of illness and/or death from L. mono is particularly serious for the elderly and immuno-compromised, which is concerning because Working Cow sold around 40% of its products to nursing homes and assisted living facilities. On October 18, Working Cow expanded its voluntary recall to include all ice cream manufactured from August 29, 2017-October 11, 2018.
Working Cow voluntarily ceased their operations and has been cooperating with the FDA. The suspension of the firm’s registration is an administrative way to allow the FDA to ensure that the firm has complied with all necessary corrective actions to protect public health before the firm resumes manufacturing and shipping ice cream products. The Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution. The FDA will reinstate Working Cow’s food facility registration only when the agency determines that the firm has eliminated the L. mono contamination and is not a threat to public health.
What are the symptoms of L. mono?
Listeriosis is a rare but serious illness usually caused by eating food contaminated with the bacteria called Listeria monocytogenes. Anyone who experiences fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or develops fever and chills while pregnant should tell their health care provider about eating a potentially contaminated food. Symptoms can appear from a few days up to a few weeks after consumption of the contaminated food. Read more about food safety tips for expectant mothers: Food Safety for Moms-To-Be: While You're Pregnant - Listeria.
Who is at risk?
Listeriosis, the third leading cause of death from food poisoning, targets pregnant women and their newborns, people with weakened immune systems, and those 65 years of age or older. Listeriosis hits these high-risk groups the hardest, accounting for at least 90 percent of reported Listeria infections and resulting in higher rates of hospitalization and death than most other foodborne bacteria. In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies.
All ice cream products manufactured by Working Cow from August 29, 2017 – October 11, 2018 have been recalled.
If you have product manufactured by Working Cow Homemade Inc. in your stores, discard it. The FDA encourages you to contact the Director of Compliance Branch at your FDA district office to discuss your product(s). The FDA is currently collecting and testing other products manufactured by Working Cow.