Crisis Management and Partnership with US Food and Drug Administration (US FDA): North Cove’s Recovery After Hurricane Helene

At the 2025 ISPE Annual Meeting & Expo, Jerry Greco, PhD, Chief Quality Officer, Baxter International Inc., and Emily Thacker, Team Leader, Drug Shortages Staff, US FDA, described how the collaborative approach to crisis management and recovery operations sustained patient access to critical sterile products.

Greco opened the sessions with context on the North Cove site’s role in the US healthcare supply chain. The facility has operated for roughly seven decades and is closely tied to its community, with multiple generations of employees contributing to its workforce. Beyond that local history, Greco underscored the site’s national significance: North Cove produces more than half of the United States’ IV solution bags and typically manufactures about 1.3 million bags per day with 46 sterilizers and a workforce of approximately 2,500 employees. Any interruption at North Cove quickly becomes a national concern for patient care, given the centrality of sterile solutions to hospital and dialysis operations.

Despite its location in the North Carolina mountains, North Cove experienced an unprecedented flooding event when Hurricane Helene struck on September 27, 2024. A levee failure near the plant sent water into manufacturing areas, inundating much of the 1.4 million square foot facility with three to four feet of water and leaving six to eight inches of mud throughout production spaces and corridors.

Greco described the scene following the storm as complete devastation. “There was no cell phone service. There was no water. There was no power… Many of our people had their homes destroyed,” he recounted.

The flood damaged access routes, including destroying a bridge connecting to the distribution center, and disabled on-site laboratories and utilities essential to sterile operations.

Greco described the pre-event preparedness steps that Baxter had executed once it became clear the storm could affect the site. They evacuated personnel, implemented a controlled shutdown of equipment to avoid electrical or mechanical damage, and moved vehicles and finished product to higher ground. Those measures did not avert the flood, but they reduced lasting equipment losses and preserved product that later helped support national demand. Baxter also established an off-site command center a few miles away to coordinate the early stages of response, a step that proved crucial in the storm’s aftermath.

Once the storm passed, Baxter began its recovery operations by focusing on its employees. With regional infrastructure devastated and many employees displaced, Baxter used the command center to account for its workforce and provide assistance. In parallel, the company began assessing inventory, physical access constraints, and options for restarting in phases. These assessments unfolded as federal and local partners arrived on site. Baxter worked with the Federal Emergency Management Agency to organize cleanup efforts. At peak activity, more than 2,000 people were engaged in cleaning, repairing infrastructure, and preparing production areas for operation.

Baxter also moved quickly to work collaboratively with the US FDA, an effort he described as shoulder-to-shoulder. The microbial implications of mud inside production zones demanded a methodical, risk-based recovery plan. The first challenge was removing the mud from the facility, he noted. The next step was to ensure that anything in the mud did not get into the product.

From the outset, Baxter’s recovery strategy paired speed with quality. Greco described the approach as a “plant-in-a-plant” restart: individual rooms and utilities would be cleaned, qualified, and brought online independently, rather than waiting for the entire facility to be restored. This compartmentalized method allowed the company to begin producing as soon as compliant zones were operational, while containing contamination risk and preserving the integrity of environmental controls. The first rooms were back in operation within four weeks, and the broader restart, including restoration of utility systems, spanned roughly four months. Across the effort, Baxter logged approximately two million labor hours.

A critical path item was utility remediation. Ponds in front of the facility supplied coolant water to the sterilizers, and they required thorough cleaning before the sterilizers could be operated. Water systems, HVAC, compressed air, and steam were sequenced in alignment with cleaning and qualification activities to support room-by-room restart. In addition to utility work, teams conducted targeted environmental monitoring to understand any changes in flora following the flood. These monitoring activities continued for months as lines came back online.

The damage to the onsite laboratories required an immediate interim solution for environmental samples. Baxter secured five mobile laboratories on a trailer and stationed them at the plant to support bioburden testing, endotoxin assays, and analytical work.

Product disposition decisions followed a risk-based framework developed in collaboration with the US FDA to determine which products could be salvaged and which could not. Baxter and the US FDA developed protocols to determine whether salvage was scientifically justified.

To minimize the national impact of reduced product output, Baxter activated its global manufacturing network. The company coordinated with international health authorities and the US FDA to enable the temporary importation of IV solutions from Baxter facilities in Canada and Asia that were not initially approved for the US market but met US standards. During this period, Baxter and federal partners also evaluated expiration date extensions for some lots—a measure intended to maximize existing inventory, supported by data and risk assessments. These steps were designed to meet patient needs while avoiding creating shortages elsewhere.

Throughout the response, Greco emphasized the collaboration with the US FDA. Agency teams conducted a preoperative site visit and remained in close contact through onsite work and regular calls, reviewing environmental monitoring strategies, water system recovery, and equipment qualification sequencing. The coordination extended to product movement decisions as the rebuilt bridge and access routes gradually improved logistics. Greco credited the joint decision-making framework for keeping the restart on track without compromising quality.

By December 2024, Baxter reported that eight of ten manufacturing lines had restarted, with output approaching 85 percent of normal capacity. That recovery trajectory drew positive remarks from US FDA leadership, including Patricia Cavazzoni, then the Director of the US FDA’s Center for Drug Evaluation and Research, who described the timeline as “remarkable.”

A tremendous effort by the manufacturer … we were able to bring that facility back online in 60 days, which is really remarkable.

Greco positioned the recovery as a practical illustration of Pharma 4.0™ concepts—transparency, speed with quality, and collaboration across organizational boundaries—applied under extreme conditions.

Emily Thacker provided the US FDA perspective, outlining how the agency’s Drug Shortages Staff operates during events in which demand meets or exceeds available supply. The team’s objective is to prevent, mitigate, and limit shortages by coordinating with manufacturers, providers, other federal agencies, and international counterparts. In the North Cove event, the Drug Shortages Staff worked closely with Baxter from the earliest stages, even as communications in the region were constrained by the storm’s impact on utilities and networks.

Thacker described how the US FDA determines when a shortage exists. The agency looks beyond local distribution issues and examines national demand versus supply, including projected demand. Manufacturers are required to notify the US FDA of potential or actual supply interruptions, including those involving finished dosage forms and active pharmaceutical ingredient (API) availability. Early notification is critical because a single manufacturer’s issue may coincide with other disruptions that are not visible to individual companies. In these circumstances, an early signal allows the agency to initiate parallel mitigation steps rather than reacting after shortages have already reached providers and patients.

In the Baxter case, the Drug Shortages Staff coordinated both internal US FDA workstreams and external communications. Internally, the team assessed whether other manufacturers could increase production and whether any regulatory reviews or inspections could be expedited to support additional supply. Externally, the staff interacted with hospitals, professional associations, and other federal bodies—including the Administration for Strategic Preparedness and Response (ASPR)—to inform prioritization and maintain situational awareness.

Thacker highlighted the tools available to the US FDA during such events. The agency can evaluate regulatory flexibilities, such as temporary importation and expiration-date extensions, when justified by data and risk assessments. It can expedite inspections or application reviews tied to restoring supply. However, the US FDA cannot require a company to manufacture more product or to reallocate supply among customers; those decisions remain with the manufacturer. In practice, the US FDA communicates the areas of greatest clinical need, shares information that may not otherwise be visible to the company, and coordinates with other manufacturers to gauge the feasibility of short-term increases in output.

A key concept in the US FDA’s approach is risk/risk evaluation. Thacker explained that, in shortage contexts, the agency weighs the risk to patients of not having a product against any added risk associated with regulatory flexibility or specific product disposition strategies. This framework does not relax quality expectations; instead, it provides a disciplined method for determining when measures such as temporary importation or expiry extensions are appropriate to prevent harm. In the Baxter scenario, these risk-based considerations supported both short-term actions and longer-term stabilization efforts.

Regarding industry best practices, Thacker underscored several points drawn from the Baxter experience. First, contingency planning should be comprehensive and regularly exercised. Baxter’s rapid mobilization, pre-event controls, and immediate contact with regulators contributed to a faster stabilization of supply. Second, transparency is essential. The Drug Shortages Staff encourages frequent updates from manufacturers, even if the news is that an issue has been resolved, because early and consistent communication can prevent unnecessary alarm among providers and reduce the likelihood of hoarding behavior. Third, companies should consider the full scope of supply chain vulnerabilities, not just finished products and API but also ancillary components and critical utilities.

She also referenced ongoing federal expectations under the CARES Act regarding risk management plans and the provision of data related to APIs and finished dosage forms. These inputs improve the US FDA’s understanding of the national landscape for critical products and its ability to anticipate cascading effects from disruptions. For companies, this level of planning and visibility supports more effective engagement with the agency during emergencies.

In the North Cove episode, Thacker noted that the combination of clear lines of communication, a defined problem-solving rhythm, and timely proposals from Baxter, such as the use of temporary importation where it would not create shortages elsewhere, helped the US FDA make decisions quickly. Those decisions were designed to keep the product flowing to patients as recovery proceeded.

Conclusion

For Baxter, the phased “plant-in-a-plant” restart, deployment of qualified mobile laboratories, restoration of water and sterilization infrastructure, and ongoing environmental monitoring combined to reestablish operations under rigorous quality oversight. For the US FDA, an early and continuous dialogue with the manufacturer, paired with risk-based use of regulatory tools, maintained patient access during a potential supply interruption.