FDA 483 - Kashiv BioSciences, LLC - March 12, 2019

Kashiv BioSciences, LLC in Chicago, IL, received a Form 483 with 7 observations during an inspection from March 4-12, 2019. The inspection revealed significant deficiencies in quality unit procedures, laboratory controls, deviation investigations, and material management. These issues indicate a lack of adherence to established protocols and scientific soundness in testing and storage, impacting the assurance of drug substance and drug product quality and purity.