FDA 483 - Actavis Italy Spa A Socio Unico - March 15, 2019

Actavis Italy S.p.A. in Nerviano, Milan, was inspected and received a Form 483 with six observations primarily concerning manufacturing controls, laboratory procedures, and record-keeping. Issues included inadequate equipment cleaning and design, failure to follow sterile product procedures, and deficiencies in stability testing and laboratory documentation. These observations indicate significant concerns regarding the firm's adherence to good manufacturing practices and quality control.