483
Kashiv BioSciences, LLCFDA 483 - Kashiv BioSciences, LLC - January 14, 2022
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Record Details
Kashiv BioSciences, LLC, a drug substance manufacturer in Chicago, Illinois, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into environmental monitoring excursions, failure to follow written procedures, and insufficient documentation and data processing controls. These issues indicate significant gaps in quality control and adherence to established manufacturing practices.
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ID · fe8ed97e-6615-4737-a6b3-f5f052694468