Baxter, a medical technology and healthcare company, has provided an update on its North Cove, North Carolina, injectables manufacturing facility, which was flooded and impacted by the rain and storm surge from Hurricane Helene, which struck parts of the Southeast, including Western North Carolina, where the facility is located, on September 26, 2024.   

Facility and supply update 
With respect to supply of product from the facility, a temporary bridge has transported more than 720 truckloads of finished product off site and to customers (as reported on October 24, 2024). The company is working on a second temporary bridge being installed at the site, with the support of the US federal government, specifically the Administration for Strategic Preparedness and Response, under the US Department of Health and Human Services, and the North Carolina Department of Transportation. This bridge, currently estimated to be completed in early November, will enable additional truck and equipment traffic to enter and leave the site.   

The company says its goal remains to begin resuming North Cove production as soon as possible and in phases by the end of this year (2024). Baxter reported that, barring any unanticipated developments, it anticipates restarting the highest-throughput IV solutions manufacturing line within the next week (as reported on October 24, 2024). 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. The company noted that the earliest that new North Cove product could begin entering the distribution channel is mid- to late-November (2024).  

Baxter says it does not yet have a timeline for when North Cove production will be fully restored to pre-hurricane levels. 

Other supply updates 
To date (as of October 24, 2024), Baxter reports that it has activated nine plants across its global network to help increase available inventory, which is contemplated in current allocation levels. Baxter reports that the US Food and Drug Administration (FDA) has authorized temporary importation for a variety of product codes from two additional Baxter manufacturing facilities in Thailand and Singapore. This brings the total number of facilities authorized for temporary importation to seven, including Canada, China (two sites), Ireland, and the UK. Baxter’s sites in Mexico and Spain were previously FDA-approved and shipments from these sites began the week of October 7, 2024.  

Last week (October 18, 2024) FDA reported that it is continuing ongoing efforts to increase access and supply of IV and peritoneal dialysis (PD) fluids and has conducted scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and PD fluids 

Baxter further reported that additional shipments of product authorized for temporary importation arrived in the US this week (as reported on October 24, 2024). The company indicated that there is a range of time when providers may begin receiving this product, and it will communicate distribution plans with customers, including direct communication to support any associated set-up and training needs.  

Source: Baxter and US Food and Drug Administration