FDA inspection
Gyrus ACMI, Inc.: FDA inspection ending Nov 12, 2025
FDA inspection 1295532 · Official Action Indicated (OAI) · Brooklyn Park, MN
Key facts
| Inspection ID | 1295532 |
|---|---|
| Firm | Gyrus ACMI, Inc. |
| FEI number | 3011050570 |
| Address | 9600 Louisiana Ave N |
| City | Brooklyn Park |
| State | MN |
| ZIP | 55445 |
| Country | United States |
| Fiscal year | 2026 |
| Inspection end date | Nov 12, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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
- 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