# KBI Biopharma, Inc., Durham, NC – FDA Inspections

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. 6 FDA inspections on record, 2 Form 483s, last inspected April 01, 2026.

---

## Details

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

## Related Documents

- [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 — classification: No Action Indicated (NAI), source: FDA, date: April 11, 2018
- FDA Inspection 937768 - KBI Biopharma, Inc. - 2015-07-16 — 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 — 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 — classification: No Action Indicated (NAI), source: FDA, date: October 9, 2009

## Related Companies

- [Chugai Pharma Manufacturing Co. Ltd. (CPMC)](https://www.keypedia.com/companies/chugai-pharma-manufacturing-co-ltd-cpmc/946be668-0540-474b-822b-8a4a81e5284f)
- [Kyowa Kirin Co., Ltd.](https://www.keypedia.com/companies/kyowa-kirin-co-ltd/9d964de3-aa1c-4983-801e-474266e4b6d2)
- [Zydus Lifesciences Limited](https://www.keypedia.com/companies/zydus-lifesciences-limited/b4ab6750-9275-47bd-a575-c425b82b300d)
- [PharmaEssentia Corporation, Taichung Plant](https://www.keypedia.com/companies/pharmaessentia-corporation-taichung-plant/97fafa0d-9006-45e0-a880-334c4e58248a)
- [ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II](https://www.keypedia.com/companies/anthem-biosciences-private-limited-phase-ii/df5d2c40-b402-492b-9369-42c7f15f0a08)
- [Regeneron Ireland Designated Activity Company](https://www.keypedia.com/companies/regeneron-ireland-designated-activity-company/74d229ed-bddb-4f75-bb07-281189fd53d4)
- [Wuxi Biologics Co Ltd](https://www.keypedia.com/companies/wuxi-biologics-co-ltd/67a28116-624d-42f6-adae-18cf80094862)
- [Daito Pharmaceutical Co., Ltd.](https://www.keypedia.com/companies/daito-pharmaceutical-co-ltd/3a27bbaf-60c1-44b3-acf3-48f8935483e8)
- [WuXi Biologics Ireland Limited](https://www.keypedia.com/companies/wuxi-biologics-ireland-limited/e760930a-5cbb-4b0f-ac1a-8eb5be3948c1)
- [FUJIFILM Diosynth Biotechnologies Texas, LLC](https://www.keypedia.com/companies/fujifilm-diosynth-biotechnologies-texas-llc/5411232a-c284-4b0d-b955-09e32761748f)

## Related Officers

- [Investigator](https://www.keypedia.com/people/lesley-satterwhite/030978c6-daaa-42e9-bf63-f90a5647f0f0)
- [recipient](https://www.keypedia.com/people/joseph-t-mcmahon/31725772-bfb8-41a3-834e-a736de0db021)
- [investigator](https://www.keypedia.com/people/daveta-l-bailey/b3c06872-638b-4c47-9539-a93b819be23f)
- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)
- [company_representative](https://www.keypedia.com/people/kathy-s-lee/9a58a1d6-cf0c-4fa2-8eed-e17b5cc7d469)