FDA inspection
HeartStitch, Inc.: FDA inspection ending Apr 27, 2016
FDA inspection 973187 · No Action Indicated (NAI) · Fountain Valley, CA
Key facts
| Inspection ID | 973187 |
|---|---|
| Firm | HeartStitch, Inc. |
| FEI number | 3009142291 |
| Address | 17074 Newhope St |
| City | Fountain Valley |
| State | CA |
| ZIP | 92708-4206 |
| Fiscal year | 2016 |
| Inspection end date | Apr 27, 2016 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None 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