Pfizer, FDA Provide Update on Pfizer’s Tornado-Damaged Facility in North Carolina
Pfizer has announced its plans to provide relief and repair the damage caused to its manufacturing facility in Rocky Mount, North Carolina, after a tornado swept through the town on July 19 (July 19, 2023).
Pfizer reported on July 21, 2023, that all 3,200 local Pfizer employees reporting to this manufacturing site are safe and accounted for, and crews are working to restore power, assess the structural integrity of the building, and move finished medicines to nearby sites for storage.
The site manufactures sterile injectables and currently manufactures nearly 25% of Pfizer’s sterile injectables. The site is closed while the damage is assessed. The US Food and Drug Administration (FDA) is working with Pfizer to assess the impact of the damage at the facility. For the products produced at the facility that are already in, or may be, at risk of shortage, the FDA has initiated mitigation steps, such as looking for additional sources and asking other manufacturers to prepare to ramp up production, if needed.
Most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance. Pfizer is working to move products to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies. Pfizer is also exploring alternative manufacturing locations for production across its US sites and internationally and across the company’s partner network. After an initial assessment, Pfizer reports that there does not appear to be any major damage to the medicine production areas.
FDA says it plans a more extensive assessment of the products that may be impacted by the damage and the current available supply of those products. The assessment also will evaluate what is in Pfizer’s other warehouses and what is stocked by wholesalers and distributors if those companies are willing to share that information with FDA.
In a statement issued on July 21, 2023, FDA says it does not expect there to be any immediate significant impacts on supply given the products manufactured at the facility are currently at hospitals and in the distribution system. Pfizer and FDA estimate that only 8% of US consumption for products manufactured at the site is supplied by the site. FDA says its initial analysis has identified less than 10 drugs for which Pfizer’s North Carolina plant is the sole source for the US market and that a number of these are specific formulations for which there should be substitutes or for which many weeks’ worth of stock should be available in Pfizer’s other warehouses.