FDA inspection
Xtreem Pulse LLC: FDA inspection ending Oct 13, 2023
FDA inspection 1220381 · Voluntary Action Indicated (VAI) · New York, NY
Key facts
| Inspection ID | 1220381 |
|---|---|
| Firm | Xtreem Pulse LLC |
| FEI number | 3012470925 |
| Address | 353 W 29th St Apt 3 |
| City | New York |
| State | NY |
| ZIP | 10001 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Oct 13, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| 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