Drug factory · FDA FEI 3004638264
KBI Biopharma, Inc.
1101 Hamlin Rd., Durham, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 1, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Sutimlimab | Tests it | Bioverativ Therapeutics Inc. | 80203-347 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 1, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2015 | No problems found | Drug Quality Assurance | — |
| Aug 29, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 9, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.