FDA 483 - Sunland, Inc. - September 23, 2010

The FDA issued a Form 483 to Sunland, Inc., a peanut manufacturer, following an inspection conducted from September 21-23, 2010. The document outlines several significant observations regarding manufacturing practices and facility conditions. A primary concern was the lack of adequate precautions to prevent contamination during production. Inspectors noted a shared sugar hopper cleaned only by dry wiping, with no cleaning of main lines between different products. An employee was observed handling food-contact surfaces of lids without proper handwashing or glove changes after touching non-food contact surfaces. A metal tool also contacted the interior of finished product containers. Furthermore, peanuts stored outside in trailers were uncovered and exposed to elements, with birds observed, posing a contamination risk. The inspection also revealed ineffective pest control measures, with open dock doors without adequate screening leading to flies in various production areas, and existing fly traps being completely full. Facility maintenance issues included exposed aggregate and cracks on a washroom floor. Personnel hygiene was inadequate, with an employee failing to properly cover their mustache. Finally, equipment design was cited, as a device used on the crunchy machine was observed to be rusty, presenting a potential source of food adulteration. This Form 483 serves as an official communication of inspectional observations, requiring Sunland, Inc. to implement corrective actions to address these deficiencies and ensure compliance with food safety regulations.