FDA 483 - Protein Sciences Corporation - May 29, 2019
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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.
ID · 0712b41a-7d92-43d9-bc84-f3e35c873976