FDA 483 - Actavis Laboratories FL, Inc. - December 01, 2017

An FDA inspection of Actavis Laboratories, FL, Inc. in Sunrise, FL, a generic drug product manufacturer, revealed significant deficiencies in its packaging and labeling systems and quality control. Observations included the presence of foreign tablets in packaging areas after cleaning, instances of mislabeling and missing lot numbers on distributed products, and a failure to adequately investigate numerous consumer complaints regarding short-counts. These issues suggest a lack of robust controls to prevent product mix-ups and ensure product quality and quantity.