FDA inspection
Xtreem Pulse LLC: FDA inspection ending Jun 19, 2019
FDA inspection 1094170 · Voluntary Action Indicated (VAI) · New York, NY
Key facts
| Inspection ID | 1094170 |
|---|---|
| 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 | 2019 |
| Inspection end date | Jun 19, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| 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
- Yes 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