FDA inspection
BrainScope Company, Inc.: FDA inspection ending Jul 13, 2023
FDA inspection 1210401 · Voluntary Action Indicated (VAI) · Chevy Chase, MD
Key facts
| Inspection ID | 1210401 |
|---|---|
| Firm | BrainScope Company, Inc. |
| FEI number | 3008660657 |
| Address | 5404 Wisconsin Ave Ste 300 |
| City | Chevy Chase |
| State | MD |
| ZIP | 20815 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Jul 13, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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