FDA EIR - Kashiv BioSciences, LLC - March 12, 2019

A pre-licensing FDA inspection of Kashiv Biosciences (formerly Adello Biosciences) was conducted from March 4-12, 2019. The inspection, which evaluated the company's readiness for manufacturing, testing, and secondary packaging of Theragrastim (Filgrastim biosimilar) under applicable regulations for drug product manufacturing and pre-approval processes, uncovered significant deficiencies. A seven-item Form FDA 483 was issued. Key violations included the Quality Unit's failure to adhere to responsibilities, such as proper review of batch disposition records, and its inability to establish adequate procedures. The FDA also cited failures in adhering to laboratory control procedures, establishing the reliability of laboratory methods, and conducting thorough investigations. Additionally, issues were noted with the appropriate storage and handling of cell banks and reference materials, as well as establishing incoming controls for components. Investigators highlighted the repeat nature of several observations, indicating persistent quality oversight concerns, especially following prior deficiencies in 2017 and 2018 that led to a 'Withhold' decision. Kashiv Biosciences management acknowledged the seriousness of the findings, promising a written response within 15 working days and initiating some corrective actions during the inspection, with the CEO verbally committing to necessary changes.