ONESOURCE SPECIALTY PHARMA LIMITED – FDA 483, Sep 1, 2022

An FDA inspection of Stelis Biopharma Limited, a combination drug-device manufacturer in Bengaluru, India, revealed significant deficiencies in their quality system. The firm failed to adequately establish and document corrective and preventive action procedures, and did not fully validate equipment and processes for assembling pen injectors. These issues indicate a lack of robust quality control over their manufacturing operations.