# FDA 483 - KBI Biopharma, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/kbi-biopharma-inc/de9bf294-ca62-4148-ad63-eca729b07ab0

> FDA 483 for KBI Biopharma, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KBI Biopharma, Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of KBI Biopharma, Inc. in Durham, North Carolina, revealed significant deficiencies in the temperature qualifications of their GMP ambient storage areas. Critical materials, including resins for Drug Substance Intermediate (DSI) production, microbial testing materials, and reagents for characterization, were found stored in unqualified ambient conditions. This indicates a serious lapse in maintaining appropriate environmental controls for sensitive manufacturing and testing components.

## Related Documents

- [483 - 2020-09-28](https://www.keypedia.com/records/483/kbi-biopharma-inc/89e7ec69-1756-4e80-833a-b36274fddfc3)
- [EIR - 2022-01-13](https://www.keypedia.com/records/eir/kbi-biopharma-inc/30c356bd-9d01-4bab-921c-1b4df3651548)

## Related Officers

- [Kamal Tiwari](https://www.keypedia.com/people/kamal-tiwari/0cb3f02d-77c1-4f61-b8bb-9b5278dae739)
- [Ayyappan Rathakrishnan](https://www.keypedia.com/people/ayyappan-rathakrishnan/4f1e717b-5d46-4f94-83c8-59eff245cc44)
- [Mercy Oyugi](https://www.keypedia.com/people/mercy-oyugi/9da8ebdc-a4c6-4666-9096-9a17f4edcf6c)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Olumide A. Martins](https://www.keypedia.com/people/olumide-a-martins/e325adf8-64a0-426a-b22f-2503e41a3f5a)

Company: https://www.keypedia.com/companies/kbi-biopharma-inc/c19eb9d6-d05c-437c-b018-992dba71d288

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd