FDA inspection
Svelte Medical Systems, Inc.: FDA inspection ending Jun 14, 2021
FDA inspection 1144067 · Voluntary Action Indicated (VAI) · New Providence, NJ
Key facts
| Inspection ID | 1144067 |
|---|---|
| Firm | Svelte Medical Systems, Inc. |
| FEI number | 3008164981 |
| Address | 675 Central Ave Ste 2 |
| City | New Providence |
| State | NJ |
| ZIP | 07974 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Jun 14, 2021 |
| 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
- 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