FDA 483 - Seqirus Inc - May 10, 2016

An FDA inspection of Seqirus Inc. (A CSL Company) in Holly Springs, NC, a licensed biological (vaccine) manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation for QA investigations into serious adverse events, improper change control classification for an SOP update, and misclassification of critical occurrences as 'Events' instead of 'Deviations'. These issues indicate a lack of robust processes for ensuring product quality, safety, and efficacy.