FDA 483 - Seqirus Inc - June 05, 2025

Seqirus Inc. in Holly Springs, NC, was inspected from May 28 to June 5, 2025, and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's quality control unit, specifically regarding unwritten procedures for deviation management and a failure to ensure timely documentation and assessment of quality events. Additionally, the firm lacked adequate written procedures for production and process controls, particularly concerning material requests during electronic system outages.