FDA 483 - Actavis Laboratories FL, Inc. - January 17, 2020

An FDA inspection of Actavis Laboratories FL, Inc. in Davie, FL, revealed significant deficiencies across its quality systems, facilities, equipment, and production controls. The firm failed to conduct timely investigations into deviations, maintain validated process hold times, provide adequate employee training, properly locate and qualify equipment, and ensure proper equipment calibration. These issues indicate a lack of control over manufacturing processes and potentially impact drug product quality.