FDA inspection
Rowny Systems, Inc.: FDA inspection ending Sep 17, 2019
FDA inspection 1102059 · Voluntary Action Indicated (VAI) · Gaithersburg, MD
Key facts
| Inspection ID | 1102059 |
|---|---|
| Firm | Rowny Systems, Inc. |
| FEI number | 3009768528 |
| Address | 6508 81st St |
| City | Gaithersburg |
| State | MD |
| ZIP | 20878 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Sep 17, 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
- 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