Baxter International, the largest manufacturer of certain intravenous (IV) solutions in the United States, shut down its North Carolina plant after being impacted by Hurricane Helene, disrupting critical supply to hospitals.
Due to the ongoing operational disruption, Baxter has “implemented allocations to help ensure we are appropriately managing our inventory and minimizing disruption to patient care.”
“That means that after review and consideration of available inventory and the medical necessity of the impacted products, a specific limit on what a customer can order has been implemented. This allocation helps limit stockpiling and increases the likelihood of equitable access to available products.”
The restrictions have been applied to saline, dextrose, and peritoneal dialysis solution products. Baxter is also working with the U.S. Food and Drug Association (FDA) to leverage the firm’s global manufacturing network to mitigate supply issues.
The group was working with state and federal partners to “implement mitigation strategies to avoid disruptions in patient care.”
Remedying Site Damage, FDA Action
Approximately 500 workers are currently on the North Cove site as part of remediation efforts.“Bridges to our site were damaged in the storm. One access point requires re-establishing the County-maintained bridge. This will allow us to both transport remediation equipment to the site and get some finished goods that were stored in trailers,” Baxter said. “Our team has worked diligently to establish a temporary bridge to support limited transfers.”
The government is planning to install a permanent bridge in the coming weeks, the firm stated.
The agency is also assessing what resources and assistance it can provide to deal with the supply situation. “This could include reviewing potential temporary imports or expediting reviews of the cleaned and restored manufacturing lines,” it said.
“As of October 1, 2024, FDA has not declared any new shortages related to products produced at the North Cove facility,” the agency said. FDA claimed it will work with alternative suppliers if required to manage shortages in critical products.
Jose E. Almeida, president and chief executive officer at Baxter, said the company will spare “no resource—human or financial” in its attempt to resume production. The North Cove facility employs 2,500 workers.
While the firm resumed manufacturing in a limited manner within a week of the storm’s passing, it wasn’t until early 2018 that the plant was able to manufacture at pre-hurricane levels.