FDA 483 - Janssen - Cilag Spa. - January 21, 2019

An FDA inspection of Janssen Cilag via C. Janssen snc in Latina, Italy, revealed significant deficiencies in laboratory controls and data integrity. The firm failed to ensure the accuracy and reliability of test results, specifically regarding the integration and reporting of degradation peaks for tablet batches. Additionally, the Empower chromatographic system software was found to be inadequately configured, with unspecified integration parameters that could prevent the detection of critical components in pharmaceutical products.