FDA EIR - Seqirus Inc - June 09, 2022

The FDA conducted a Level 1 inspection of Seqirus Inc. in Holly Springs, NC, from June 1-9, 2022. This inspection, carried out under the Team Biologics FY'2022 work plan and Compliance Program CP7345.848C for biological drug products, focused on the company's Quality, Production, Laboratory Control, and Facilities and Equipment systems. The review covered biological products such as Flucelvax, Fluad Quadrivalent, and the MF59C.1 adjuvant.

The inspection revealed several deficiencies, leading to the issuance of a Form FDA 483. Noteworthy observations included the company's failure to report adverse experience information for six serious unexpected events and four follow-up reports with new information to the FDA within the mandated 15 calendar days. Additionally, the firm did not thoroughly investigate an unexplained discrepancy concerning a power outage that affected the HVAC system and critical manufacturing areas. There were also instances where quality control unit procedures were not fully followed, specifically classifying deviations at a lower category despite potential impact on product attributes, and 22 deviations were initiated beyond the company's specified timeframe.

Seqirus Inc. management has voluntarily committed to submitting a written response addressing these deficiencies to the FDA within 15 days.