FDA 483 - Kashiv BioSciences, LLC - November 21, 2017

An FDA inspection of Adello Biologics, LLC in Chicago, IL, a drug substance and drug product manufacturing facility, revealed significant deficiencies in quality oversight, laboratory procedures, and deviation investigations. The firm also failed to adequately control critical materials after temperature excursions and did not consistently follow written procedures for logbook management and validation. Inadequate written procedures for pest control were also noted.