Company
United StatesKBI Biopharma, Inc., Durham, NC – FDA Inspections
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.
Company Profile
This profile covers KBI Biopharma, Inc. based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected October 9, 2009. Last inspected April 1, 2026.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 1, 2026 | Not classified | Human Drugs | 1312108 |
| June 18, 2024 | Not classified | Human Drugs | 1241524 |
| April 11, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1051652 |
| July 16, 2015 | NAI | Human Drugs · Drug Quality Assurance | 937768 |
| August 29, 2012 | NAI | Human Drugs · Drug Quality Assurance | 796226 |
| October 9, 2009 | NAI | Human Drugs · Drug Quality Assurance | 625271 |
FDA documents
People (5)
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Company Information
Name
KBI Biopharma, Inc.
FEI Number
3004638264
Address
1101 Hamlin Rd, Durham, North Carolina 27704, United States
Country
United States
ID: c19eb9d6-d05c-437c-b018-992dba71d288