FDA inspection
The American National Red Cross Diagnostic Manufacturing Division: FDA inspection ending Dec 4, 2009
FDA inspection 636469 · Voluntary Action Indicated (VAI) · Gaithersburg, MD
Key facts
| Inspection ID | 636469 |
|---|---|
| Firm | The American National Red Cross Diagnostic Manufacturing Division |
| FEI number | 1177732 |
| Address | 9319 Gaither Rd |
| City | Gaithersburg |
| State | MD |
| ZIP | 20877 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Dec 4, 2009 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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