FDA EIR - Kashiv BioSciences, LLC - November 21, 2017

An FDA inspection of Adello Biologics, LLC.'s bulk drug substance manufacturing facility in Chicago, IL, took place from November 13-17 and 20-21, 2017. This inspection was conducted to support a Biologics License Application (BLA) for Theragrastim (a biosimilar to Neupogen) and followed regulatory frameworks outlined in Compliance Program 7356.002M and ICH Q7. At the conclusion, an amended six-item Form FDA 483 was issued to company management, detailing significant deficiencies. The main issues included inadequate quality oversight across operations, indicating potential systemic weaknesses in the quality management system. Inspectors also found insufficient laboratory procedures, which could compromise testing and data integrity. The firm's deviation investigation process was deemed inadequate, potentially hindering effective root cause analysis. Furthermore, there was inadequate control over critical materials, posing risks to product quality and supply chain. Lastly, the report cited issues with written procedures, noting that they were not consistently followed and were, in some cases, inherently insufficient. Adello Biologics, LLC. is required to address these observations comprehensively to ensure compliance with pharmaceutical manufacturing regulations.