FDA 483 - KBI Biopharma, Inc. - December 03, 2021

KBI Biopharma, Inc. in Boulder, CO, a drug substance manufacturer, received a Form 483 citing two observations related to quality control deficiencies. The firm failed to conduct complete investigations into contamination events within its water generation system, often leaving root causes undetermined. Additionally, equipment maintenance procedures were found to be deficient, with critical processing equipment lacking established cleaning schedules and numerous pressure gauges remaining uncalibrated.