FDA 483 - LSNE-Leon, SLU - October 08, 2018

During a pre-approval inspection, Gadea Biopharma S.L. in León, Spain, was cited for significant discrepancies between its drug application and on-site capabilities, particularly regarding labeling operations. The inspection also revealed a lack of established written procedures for labeling and packaging, and critical issues with the integrity and availability of Certificates of Analysis and their supporting raw data. These findings indicate serious deficiencies in quality control and data management for a contract sterile injectable drug products manufacturer.