# FDA 483 - KBI Biopharma, Inc. - April 01, 2026

Source: https://www.keypedia.com/records/483/kbi-biopharma-inc/e8056555-57db-48c7-82f7-bc168dca579c

> FDA 483 for KBI Biopharma, Inc. on April 01, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KBI Biopharma, Inc.
- Inspection Date: 2026-04-01
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: KBI Biopharma Inc. in Durham, NC, a drug substance manufacturer, received an FDA Form 483 citing significant quality system deficiencies. Observations included inadequate environmental controls in ISO 5 areas, failure to follow validated monitoring procedures, and insufficient investigation and documentation of invalid assay results. The firm also failed to maintain proper chain of custody for samples, adequately address deviations with effective CAPAs, and perform required annual product quality reviews.

## Related Documents

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- [483 - 2020-09-28](https://www.keypedia.com/records/483/kbi-biopharma-inc/89e7ec69-1756-4e80-833a-b36274fddfc3)

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7