483
KBI Biopharma, Inc.FDA 483 - KBI Biopharma, Inc. - March 02, 2020
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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.
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ID · a75c9695-e699-443b-997c-1d7fc59b8dd4