Crisis Management and Partnership with FDA to Overcome Supply Chain Disruptions, Ensure Quality and Maintain Operational Excellence
In 2024, Baxter faced Hurricane Helene, a category 4 hurricane that struck our North Cove facility, the largest manufacturer of intravenous and peritoneal dialysis products in the US. Through a close partnership with the FDA, the threat of shortage was remediated within a 3-month timeframe. In December of 2024, Baxter restarted 8 of 10 manufacturing lines and began to function at close to 85% of normal capacity. Patrizia Cavazzoni (former director of CDER) noted during her exit interview that through this partnership and “a tremendous effort by the manufacturer … we were able to bring that facility back online in 60 days, really is remarkable." We would like to share the lessons learned during the path to recovery recognized by the FDA around manufacturing, quality control, operational excellence, and supply chain resilience. Streamlining operations and ensuring quality by design were among the critical activities in order to resume manufacturing at the site. Through a robust supply chain strategy and adaptive capabilities, Baxter was able to mitigate significant shortages during a time of unexpected disruptions and recover quickly by maintaining the continuity of operations.
In 2024, Baxter faced Hurricane Helene, a category 4 hurricane that struck our North Cove facility, the largest manufacturer of intravenous and peritoneal dialysis products in the US. Through a close partnership with the FDA, the threat of shortage was remediated within a 3-month timeframe. In December of 2024, Baxter restarted 8 of 10 manufacturing lines and began to function at close to 85% of normal capacity. Patrizia Cavazzoni (former director of CDER) noted during her exit interview that through this partnership and “a tremendous effort by the manufacturer … we were able to bring that facility back online in 60 days, really is remarkable." We would like to share the lessons learned during the path to recovery recognized by the FDA around manufacturing, quality control, operational excellence, and supply chain resilience. Streamlining operations and ensuring quality by design were among the critical activities in order to resume manufacturing at the site. Through a robust supply chain strategy and adaptive capabilities, Baxter was able to mitigate significant shortages during a time of unexpected disruptions and recover quickly by maintaining the continuity of operations.
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