# FDA 483 - KBI Biopharma, Inc. - September 28, 2020

Source: https://www.globalkeysolutions.net/records/483/kbi-biopharma-inc/89e7ec69-1756-4e80-833a-b36274fddfc3

> FDA 483 for KBI Biopharma, Inc. on September 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KBI Biopharma, Inc.
- Inspection Date: 2020-09-28
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of KBI Biopharma, Inc. in Durham, NC, a drug substance manufacturer, revealed five observations primarily concerning the firm's quality unit. The findings indicate significant deficiencies in quality control unit responsibilities, data integrity controls for computerized systems, investigation and resolution of critical deviations, adherence to standard operating procedures, and employee training. These issues collectively point to a lack of robust quality system oversight and control.

## Related Documents

- [EIR - 2022-01-13](https://www.globalkeysolutions.net/records/eir/kbi-biopharma-inc/30c356bd-9d01-4bab-921c-1b4df3651548)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/kbi-biopharma-inc/de9bf294-ca62-4148-ad63-eca729b07ab0)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/agarabi-cyrus/294ea042-7e80-47be-a05d-d172b9799e51)
- [FDA Biologics Investigator](https://www.globalkeysolutions.net/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321