FDA EIR - Seqirus Inc - May 17, 2016

An FDA inspection of Seqirus Inc.'s Holly Springs, NC facility occurred from May 10-17, 2016. Conducted under the regulatory framework of cGMP and CP 7345.848 for biological drug products, the assessment covered the Quality, Production, Facilities and Equipment, and Laboratory Systems for the licensed vaccine manufacturer, which produces Flucelvax®. The inspection resulted in a four-item FDA-483, Inspectional Observations. Primary violations included deficient quality investigations for serious adverse events, where conclusions lacked thoroughness on potential impacts to product safety, purity, and efficacy. Additionally, a sampling plan for assessing product variation was inadequate, failing to characterize variability, and no regulatory assessment was performed for a related change. Issues were also noted with the improper classification of certain deviations from storage conditions and an incomplete product impact assessment in a deviation report. These findings highlight the need for Seqirus Inc. to enhance its quality control and investigational processes. The issuance of the FDA-483 formally requires the company to develop and implement comprehensive corrective and preventive actions to rectify these observed deficiencies and ensure ongoing compliance with cGMP. This inspection followed a more extensive 14-item FDA-483 issued in February 2014, for which several corrections had been adequately addressed.