By Kathy Knutson, Ph.D. In October 2018 FDA suspended the registration of Working Cow Homemade, Inc., of Florida. Working Cow is an ice cream manufacturer, ceased operations, and has cooperated with FDA. As part of its decision to suspend their registration FDA determined:
- Insanitary conditions were observed during inspections in both 2017 and 2018.
- Following a 2017 inspection, an environmental sample tested positive for Listeria monocytogenes. Per FDA protocol, the whole genome sequencing data for the pathogen was uploaded to the Genome Trakr database.
- In 2017, Working Cow conducted a recall. According to FDA, Working Cow did not implement corrective actions after the 2017 findings and recall.
- In September 2018, the CDC informed the Florida Department of Health of a genetic match between the 2017 environmental Listeriaand a 2018 patient plus two patients in 2013.
- Working Cow has a Florida customer base that includes potentially immunocompromised adult consumers at nursing homes and assisted living facilities.
- A 2018 Listeria monocytogenes environmental isolate matched the 2017 environmental isolate, making the pathogen a potential resident strain.
- Zone 1 – Direct product contact & indirect product contact (surfaces from which contaminants can drip, drain or be drawn onto product contact surfaces), includes pressurized air
- Zone 2 – Equipment non-product contact areas immediately adjacent to processing equipment
- Zone 3 – Facility non-product contact areas within processing, packaging & ingredient/finished product cooler areas, i.e. floors; walls; ceilings; overhead piping, conduit & structural supports; drains; forklifts & pallet jacks that enter processing & packaging areas
- Zone 4 – Facility and equipment non-product contact areas located outside of the processing, packaging & ingredient/finished product cooler areas, i.e. warehouses, dock areas, break rooms, hallways
Posted in EASeNews, Foods, Issue of the Month and tagged Kathy Knutson.