FDA inspection
ImpactOrtho Inc Hawaii: FDA inspection ending Feb 28, 2019
FDA inspection 1080781 · Voluntary Action Indicated (VAI) · Honolulu, HI
Key facts
| Inspection ID | 1080781 |
|---|---|
| Firm | ImpactOrtho Inc Hawaii |
| FEI number | 3014328922 |
| Address | 770 Kapiolani Blvd Ste 615 |
| City | Honolulu |
| State | HI |
| ZIP | 96813 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Feb 28, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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