FDA 483 - Quality Formulation Laboratories, Inc. - January 13, 2009

This FDA Form 483 document outlines several significant observations made during an inspection, indicating a lack of adherence to good manufacturing practices and sanitation standards. The facility is cited for failing to implement effective measures to exclude pests from processing areas, leading to potential contamination of food. Food-contact surfaces and utensils are not being cleaned as frequently as necessary, and the cleaning and sanitizing procedures for equipment and utensils have not been demonstrated to be adequate. Consequently, equipment and utensils are not maintained in an acceptable sanitary condition.

Further observations include a failure to manufacture, package, and store foods under conditions and controls necessary to minimize contamination. The facility also lacks a designated competent individual or individuals responsible for supervising overall plant sanitation. Finally, food handlers and supervisors have not received appropriate training in food handling techniques and food protection principles. These observations collectively point to systemic issues in sanitation, pest control, equipment maintenance, and personnel training, which could lead to significant food safety risks and potential product contamination.