# KBI Biopharma, Inc. - Inspection Records

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

> Inspection records and compliance data for KBI Biopharma, Inc. in Durham, North Carolina. Access full analysis and detailed observations.

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## Details

- Name: KBI Biopharma, Inc.
- FEI Number: 3004638264
- City: Durham
- State: North Carolina
- Country Name: United States
- Address Line 1: 1101 Hamlin Rd
- Zip Code: 27704

## Related Documents

- [483 - KBI Biopharma, Inc. - Unknown Date](https://www.keypedia.com/records/483/kbi-biopharma-inc/de9bf294-ca62-4148-ad63-eca729b07ab0) — source: FDA, date: Invalid Date
- [483 - KBI Biopharma, Inc. - 2026-04-01](https://www.keypedia.com/records/483/kbi-biopharma-inc/e8056555-57db-48c7-82f7-bc168dca579c) — source: FDA, date: April 1, 2026
- [FDA Inspection 1312108 - KBI Biopharma, Inc. - 2026-04-01](https://www.keypedia.com/records/fda_inspections/kbi-biopharma-inc/c23fd1bf-6113-4a1b-956d-885f190a4130) — source: FDA, date: April 1, 2026
- [483 - KBI Biopharma, Inc. - 2024-06-18](https://www.keypedia.com/records/483/kbi-biopharma-inc/b29e38b1-6621-46f6-8e10-a7993d40dd39) — source: FDA, date: June 18, 2024
- [FDA Inspection 1241524 - KBI Biopharma, Inc. - 2024-06-18](https://www.keypedia.com/records/fda_inspections/kbi-biopharma-inc/5cd2e622-d49c-44b5-b6e3-44ca23f7bcc6) — source: FDA, date: June 18, 2024
- [EIR - KBI Biopharma, Inc. - 2022-01-13](https://www.keypedia.com/records/eir/kbi-biopharma-inc/30c356bd-9d01-4bab-921c-1b4df3651548) — source: FDA, date: January 13, 2022
- [EIR - KBI Biopharma, Inc. - 2020-09-29](https://www.keypedia.com/records/eir/kbi-biopharma-inc/17f315b5-ae84-4a01-b769-5d63fba6b1c2) — source: FDA, date: September 29, 2020
- [483 - KBI Biopharma, Inc. - 2020-09-28](https://www.keypedia.com/records/483/kbi-biopharma-inc/89e7ec69-1756-4e80-833a-b36274fddfc3) — source: FDA, date: September 28, 2020
- [EIR - KBI Biopharma, Inc. - 2018-04-11](https://www.keypedia.com/records/eir/kbi-biopharma-inc/9b62802a-6328-46f0-b134-39ceba47ca3f) — source: FDA, date: April 11, 2018
- [FDA Inspection 1051652 - KBI Biopharma, Inc. - 2018-04-11](https://www.keypedia.com/records/fda_inspections/kbi-biopharma-inc/5932eca4-bc32-4948-90a3-7be684abefc9) — classification: No Action Indicated (NAI), source: FDA, date: April 11, 2018
- [FDA Inspection 937768 - KBI Biopharma, Inc. - 2015-07-16](https://www.keypedia.com/records/fda_inspections/kbi-biopharma-inc/2a24b57f-300f-49d3-b234-78ecaded8d95) — classification: No Action Indicated (NAI), source: FDA, date: July 16, 2015
- [EIR - KBI Biopharma, Inc. - 2012-08-29](https://www.keypedia.com/records/eir/kbi-biopharma-inc/4c248db7-4935-40ba-a8dc-8cfff5b67bcf) — source: FDA, date: August 29, 2012
- [FDA Inspection 796226 - KBI Biopharma, Inc. - 2012-08-29](https://www.keypedia.com/records/fda_inspections/kbi-biopharma-inc/afcc769a-43bd-4ff3-a80b-aba4b1c1848e) — classification: No Action Indicated (NAI), source: FDA, date: August 29, 2012
- [EIR - KBI Biopharma, Inc. - 2009-10-09](https://www.keypedia.com/records/eir/kbi-biopharma-inc/28d69679-89a7-4a67-9afc-aa9fbe2698b7) — source: FDA, date: October 9, 2009
- [FDA Inspection 625271 - KBI Biopharma, Inc. - 2009-10-09](https://www.keypedia.com/records/fda_inspections/kbi-biopharma-inc/6a0866c2-378e-428b-8824-cf305300302d) — classification: No Action Indicated (NAI), source: FDA, date: October 9, 2009

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## Related Officers

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- [company_representative](https://www.keypedia.com/people/kathy-s-lee/9a58a1d6-cf0c-4fa2-8eed-e17b5cc7d469)
