FDA 483 - Allergan Sales, LLC - February 27, 2019

An FDA inspection of Allergan Sales, LLC in Waco, TX, a sterile drug manufacturer, revealed three significant observations. The firm was cited for inadequate procedures to prevent microbiological contamination, deficiencies in environmental monitoring systems, and issues with cleaning and disinfection protocols in aseptic processing areas. These findings indicate potential risks to the sterility of drug products.