FDA 483 - Kashiv BioSciences, LLC - June 14, 2024

Kashiv BioSciences, LLC, a drug substance and sterile drug product manufacturer in Chicago, IL, was cited for significant deficiencies across six observations during an FDA inspection. The firm failed to adequately investigate discrepancies, maintain control over GMP documents, adhere to written production and process control procedures, ensure data integrity for electronic systems, and properly manage the storage and identification of drug components. These issues indicate a systemic lack of adherence to good manufacturing practices.