FDA 483 - Kashiv BioSciences, LLC - January 22, 2018

Adello Biologics LLC, a drug substance and drug product manufacturing facility in Chicago, IL, was cited for significant data integrity and quality control issues during an FDA inspection. Observations included failures in ensuring scientifically sound test procedures, inadequate review of analytical data, insufficient controls to prevent data manipulation, and poor control over GMP documents. These findings indicate a systemic lack of robust quality systems.