Medical equipment manufacturer Baxter said it expects to restart one of its highest-throughput IV solutions manufacturing lines within the next week after it was forced to close down its North Carolina factory following flooding caused by Hurricane Helene.
The company said initial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products. It also warned that the earliest that new IV fluid product from its North Cove facility would enter distribution channels is mid- to late-November.
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“This is, however, ahead of our original expectations and is a testament to the urgency, diligence and resiliency of the North Cove and broader Baxter teams as we’ve worked to accelerate recovery, with the support of FDA, ASPR and HHS,” the company wrote, while advising that it still doesn’t have a date for when North Cove will return to pre-hurricane production levels.
While Baxter works to restore full production at its facility, which it said sustained no structural damage during the flood, the company has been working with the FDA on temporary authorization to import IV fluid from Baxter’s facilities in other countries. The company said today that its facilities in Thailand and Singapore have been added to the list of approved suppliers.
Baxter placed limits on U.S. allocations for IV fluid after its factory shut down. However, the company said based on the current status of our North Cove remediation efforts, its expectations regarding its ability to reallocate capacity from other Baxter facilities, and temporary importation on certain products, its goal remains to return to 90% to 100% allocation of certain IV solution product codes for U.S. customers by the end of 2024.
The North Cove facility in Marion, N.C., which employs more than 2,500 people, focuses primarily on making intravenous and peritoneal dialysis solutions. The company said it’s the country’s largest manufacturer of these solutions