FDA 483 - Wholesome Soy Products Inc. - October 31, 2014

During an FDA inspection conducted between October 7 and October 31, 2014, Wholesome Soy Products Inc., a sprout grower and tofu manufacturer, was issued a Form FDA 483 detailing numerous significant deficiencies. The observations highlight concerns regarding hygiene, sanitation, and facility maintenance, which could compromise product safety. Key issues in the sprout growing operation included the repeated detection of Listeria monocytogenes in the production environment and warehouse. Employee practices were observed to facilitate cross-contamination, such as inadequate handwashing, re-entry to processing areas without sanitizing gear, and improper waste handling. Equipment was poorly maintained, and cleaning procedures were found to be insufficient, evidenced by mold-like growth and cracks in floors. Pest control was ineffective, with flying insects present. Many of these issues were repeat observations from a prior inspection. In the tofu manufacturing area, similar issues were noted, including inadequate employee hygiene, unsanitary equipment handling, and plant design that hindered proper cleaning. Pests were also present in this area, and critical measuring instruments were found to be uncalibrated. The repeated nature of several observations indicates a systemic failure to implement effective corrective actions following previous inspections. The company is required to respond to these observations, outlining comprehensive corrective and preventive actions to ensure compliance with food safety regulations and prevent potential product adulteration.