FDA 483 - KBI Biopharma, Inc. - March 02, 2020

KBI Biopharma, Inc. in Boulder, Colorado was inspected from March 2-6, 2020, and received one observation. The inspection revealed that a characterization study performed to evaluate pegfilgrastim drug substance did not meet system suitability criteria. This failure invalidated the final quality control analytical results, indicating a potential issue with analytical method control.