FDA 483 - Protein Sciences Corporation - May 02, 2024

An FDA inspection of Protein Sciences Corporation in Pearl River, NY, revealed significant deficiencies in their manufacturing and quality control processes for Flublok drug products. Key issues included inadequate laboratory controls, failure to properly investigate deviations and out-of-specification results, and poor environmental monitoring and facility maintenance. These findings indicate a lack of robust quality systems impacting product quality and safety.