FDA inspection
KBI Biopharma, Inc.: FDA inspection ending Sep 29, 2020
FDA inspection 1134456 · Official Action Indicated (OAI) · Durham, NC
Key facts
| Inspection ID | 1134456 |
|---|---|
| Firm | KBI Biopharma, Inc. |
| FEI number | 3004638264 |
| Address | 1101 Hamlin Rd |
| City | Durham |
| State | NC |
| ZIP | 27704-9658 |
| Fiscal year | 2020 |
| Inspection end date | Sep 29, 2020 |
| Classification | Official Action Indicated (OAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data