FDA EIR - LSNE-Leon, SLU - October 16, 2018

An FDA pre-approval inspection of Gadea Biopharma S.L., a contract sterile drug manufacturer in Leon, Spain, was conducted from October 8-16, 2018. The inspection, part of the FDA's pre-approval program under Compliance Program 7346.832, aimed to verify readiness for commercial manufacturing, conformance to drug applications, and data integrity, in line with current Good Manufacturing Practices (cGMP) regulations (21 CFR 210 and 211). At its conclusion, an FDA-483, Inspectional Observations, was issued. Key observations included discrepancies between information in submitted drug applications and actual on-site capabilities, particularly regarding vial labeling equipment and operations. The firm lacked qualified labeling equipment and established written procedures for labeling and packing. Additionally, Certificate of Analysis data in the drug application did not align with raw analytical test records, and original records were unavailable. The firm also lacked a written procedure for managing changes in Certificate of Analysis versions. During the inspection, Gadea Biopharma made voluntary corrections, such as calibrating a compounding vessel and updating gowning procedures. The issuance of the FDA-483 requires the firm to provide a formal response addressing these observations.