FDA inspection
Pulmodyne Inc.: FDA inspection ending Apr 22, 2025
FDA inspection 1268055 · Official Action Indicated (OAI) · Indianapolis, IN
Key facts
| Inspection ID | 1268055 |
|---|---|
| Firm | Pulmodyne Inc. |
| FEI number | 1832562 |
| Address | 2055 Executive Dr |
| City | Indianapolis |
| State | IN |
| ZIP | 46241 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Apr 22, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: 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
- 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