FDA EIR - AGC Biologics A/S - November 05, 2019

An FDA inspection of AGC Biologics A/S in Soeborg, Denmark, was conducted from October 28 to November 5, 2019, focusing on their drug substance manufacturing operations. The inspection identified several deficiencies in adherence to current Good Manufacturing Practices (GMP), resulting in the issuance of an FDA Form 483 with eight observations. Main issues included the performance of manufacturing steps not approved by the Quality Unit or documented in master batch records, and inadequate procedures for allocating equipment and materials to ensure manufacturing operations followed master batch record instructions. Additionally, batch records were not consistently documented in sequence, and Quality Assurance failed to properly follow non-conformance procedures, particularly concerning recurring deviations in stability testing. The inspection also highlighted inadequacies in Quality Control procedures, insufficient documentation for investigations into assay failures, and a lack of scientifically sound laboratory controls for drug substance and product testing. Lastly, the batch record review process was found to be inadequate. AGC Biologics A/S is required to address these observations by implementing appropriate corrective and preventive actions to ensure compliance with regulatory standards.