FDA 483 - Setton International Foods, Inc. - April 08, 2009

An FDA inspection of Setton International Foods, Inc., a manufacturer and repacker, conducted from March 31 to April 8, 2009, revealed several significant food safety concerns. The observations, detailed in a Form FDA 483, highlighted a failure to maintain adequate sanitation and hygiene practices. Key issues included a deficient cleaning and sanitizing program for utensils and equipment, where standard operating procedures lacked a crucial wash step before sanitization, and equipment like roasters received insufficient cleaning. Employees were observed not washing hands thoroughly when their hands became soiled or contaminated, particularly when handling ready-to-eat foods. Furthermore, the facility lacked essential handwashing stations in key processing areas like the Packaging, Panning, Organic, and Roasting Rooms, limiting proper hygiene. Other observations noted employees, including management, failing to wear appropriate or effective hair restraints, including for facial hair, in food processing areas. Finally, an uncovered light fixture was positioned directly over exposed food (unroasted cashews) in the Roasting Room, posing a contamination risk. Setton International Foods is required to address these observations by implementing comprehensive corrective actions to ensure compliance with food safety regulations and protect public health.