FDA 483 - Kashiv BioSciences, LLC - November 21, 2022

Kashiv BioSciences, LLC, a biological drug substance and drug product manufacturer in Chicago, IL, was cited with eight observations during an FDA inspection. The inspection revealed significant deficiencies across multiple areas, including inadequate aseptic process simulations, insufficient investigations into batch failures, and deficiencies in visual inspection programs and employee training. Additionally, issues were noted with cleaning and sanitization, component testing, process validation, and the stability program for Theragrastim pre-filled syringes.