FDA 483 - Seqirus Inc - June 05, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · e8a3587e-efc6-409b-84c7-9cf11e02c14f