FDA 483 - Protein Sciences Corporation - March 17, 2026

An FDA inspection of Protein Sciences Corporation in Pearl River, NY, a manufacturer of Flublok recombinant influenza vaccine, revealed significant deficiencies across multiple areas. Observations included inadequate inventory controls for critical starting materials, unvalidated computerized systems for quality data, and failures in preventing microbiological contamination due to poor material flow, aseptic technique, and equipment maintenance. Additionally, the Quality Unit demonstrated a lack of effective oversight in addressing recurring deviations.