FDA inspection
Premier Heart, LLC: FDA inspection ending Feb 8, 2018
FDA inspection 1040432 · Voluntary Action Indicated (VAI) · Port Washington, NY
Key facts
| Inspection ID | 1040432 |
|---|---|
| Firm | Premier Heart, LLC |
| FEI number | 3003289183 |
| Address | 110 Main St Ste 201 |
| City | Port Washington |
| State | NY |
| ZIP | 11050 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Feb 8, 2018 |
| 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