AGC Biologics A/S – FDA EIR, Nov 5, 2019

The U.S. Food and Drug Administration (FDA) conducted an inspection of AGC Biologics A/S in Soeborg, Denmark, between October 28 and November 5, 2019, focusing on drug substance manufacturing operations. The inspection identified eight significant deviations from regulatory expectations, resulting in the issuance of an FDA Form 483. Main issues included performing manufacturing steps not authorized by the Quality Unit and not documented in master batch records, and inadequate procedures for equipment and material allocation, which led to materials being used while still under quarantine due to insufficient planning. The company's Quality Assurance also failed to adhere to non-conformance procedures, evidenced by recurring delays in stability testing and a lack of proper investigations. Additionally, batch record documentation did not consistently follow the approved sequence, and the review process was inadequate, missing critical process excursions. Other observations highlighted inadequate Quality Control procedures, insufficient documentation for assay failure investigations, and a lack of scientifically sound laboratory controls for drug substance and product testing. These findings necessitate the implementation of comprehensive corrective and preventive actions to ensure compliance with current Good Manufacturing Practices.