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

Source: https://www.globalkeysolutions.net/records/483/kbi-biopharma-inc/a75c9695-e699-443b-997c-1d7fc59b8dd4

> FDA 483 for KBI Biopharma, Inc. on March 02, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KBI Biopharma, Inc.
- Inspection Date: 2020-03-02
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [EIR - 2020-03-06](https://www.globalkeysolutions.net/records/eir/kbi-biopharma-inc/51d34223-d6bd-4055-8159-1b61f966c64a)
- [483 - 2021-12-03](https://www.globalkeysolutions.net/records/483/kbi-biopharma-inc/5239f5c8-755b-47b0-ba48-fbecb11890fe)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/genoula-k-ryan/aff42022-4538-43e3-b022-39b66e4bbea5)
- [Compliance Officer / Investigator](https://www.globalkeysolutions.net/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.globalkeysolutions.net/companies/kbi-biopharma-inc/0116f415-95dd-4a3f-a854-182d0314d5a5

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face