FDA 483 - Smithfield Bioscience Inc - October 27, 2016

Celsus Laboratories Inc. in Cincinnati, OH, received a Form 483 citing significant deficiencies in laboratory computer system validation, electronic data oversight, and testing procedures. The inspection also found issues with document control for production batch records, indicating a lack of robust quality unit controls. These observations highlight concerns regarding data integrity and adherence to established manufacturing practices for an API manufacturer.