Case Study
Regulatory roadblock - FDA suspends peanut butter plant due to E. coli outbreak
Case study Regulatory roadblock FDA suspends peanut butter plant due to E. coli outbreakAll domestic and foreign companies that manufacture, process or pack food for consumption in the US must have their registration renewed with the Department of Human Health and Services (HSS) every two years. This is mandated under the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA). The FDA now has the power under FSMA to suspend the registration of a facility if the agency determines food has a reasonable probability of causing death or other serious harm to animals or humans. In this case study, we explore how a peanut butter manufacturer had their facility suspended due to an E. coli outbreak, which resulted in a total halt on production and a ban on selling food