FDA 483 - Protein Sciences Corporation - May 29, 2026

An FDA inspection of Protein Sciences Corporation in Pearl River, NY, a recombinant influenza virus manufacturer, revealed significant deficiencies. The firm was cited for incomplete and untimely complaint and deviation investigations, inadequate validation studies for raw materials, and a lack of quality oversight for contract services. Additionally, corrective and preventive actions were not implemented in a timely manner, indicating systemic issues in their quality management system.