FDA inspection
HeartStitch, Inc.: FDA inspection ending Jun 25, 2025
FDA inspection 1273782 · Voluntary Action Indicated (VAI) · Fountain Valley, CA
Key facts
| Inspection ID | 1273782 |
|---|---|
| Firm | HeartStitch, Inc. |
| FEI number | 3009142291 |
| Address | 17074 Newhope St |
| City | Fountain Valley |
| State | CA |
| ZIP | 92708 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Jun 25, 2025 |
| 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