FDA inspection
Presbyterian/St. Luke's Medical Center Donor Services: FDA inspection ending Apr 22, 2019
FDA inspection 1087028 · Voluntary Action Indicated (VAI) · Denver, CO
Key facts
| Inspection ID | 1087028 |
|---|---|
| Firm | Presbyterian/St. Luke's Medical Center Donor Services |
| FEI number | 1770151 |
| Address | 1719 E 19th Ave |
| City | Denver |
| State | CO |
| ZIP | 80218 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Apr 22, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 10–99 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