FDA 483 - Seqirus Inc - June 05, 2025

During an inspection conducted from May 28 to June 5, 2025, the Food and Drug Administration (FDA) identified significant quality management issues at the Seqirus Inc manufacturing facility in Holly Springs, North Carolina. The report, issued to Site Head Jonathan Kegerise, outlines two primary areas of concern regarding the facility's compliance with safety and quality standards.

First, the FDA observed that the Quality Control Unit failed to establish written procedures for timely deviation management. Specifically, the site did not ensure that quality-related events were recorded and assessed immediately upon discovery. Investigators identified multiple instances where the firm waited between eight months and four years after an event occurred to initiate a formal quality record. Such delays hinder the ability to accurately determine the impact of these events on product quality.

Second, the facility lacked documented protocols for production and process controls during unplanned outages of their electronic inventory system. While the firm continued to request materials for drug manufacturing during these outages, they had no written procedures to govern the process, potentially compromising the identity and purity of the products.

These observations were issued pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act. Seqirus Inc is required to respond to these findings by either contesting the observations or submitting a detailed plan for corrective actions to the FDA’s Atlanta District Office.