FDA 483 - Cilag AG - July 16, 2019

An FDA inspection of Cilag AG, a drug manufacturer in Schaffhausen, Switzerland, revealed four observations related to quality system deficiencies. These included issues with equipment maintenance, failure to follow established microbiological test procedures, and incomplete laboratory records for instrument calibration and endotoxin testing traceability. The findings indicate a need for improved adherence to good manufacturing practices and documentation standards.