FDA 483 - Merck & Cie - November 02, 2018

During an inspection of Merck & Cie, an API manufacturer in Schaffhausen, Switzerland, the FDA observed significant deficiencies in the control of computer and laboratory systems. Specifically, laboratory personnel were assigned administrator roles allowing data manipulation, and the chromatographic software lacked essential audit trail capabilities. These findings indicate a lack of appropriate controls over electronic raw data and potential data integrity issues.