FDA inspection
KBI Biopharma, Inc.: FDA inspection ending Dec 3, 2021
FDA inspection 1158021 · Voluntary Action Indicated (VAI) · Boulder, CO
Key facts
| Inspection ID | 1158021 |
|---|---|
| Firm | KBI Biopharma, Inc. |
| FEI number | 3011326133 |
| Address | 2500 Central Ave |
| City | Boulder |
| State | CO |
| ZIP | 80301 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Dec 3, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| 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