FDA inspection
Heartsine Technologies Inc: FDA inspection ending Aug 22, 2013
FDA inspection 847671 · Official Action Indicated (OAI) · Newtown, PA
Key facts
| Inspection ID | 847671 |
|---|---|
| Firm | Heartsine Technologies Inc |
| FEI number | 3004018643 |
| Address | 121 Friends Ln Ste 400 |
| City | Newtown |
| State | PA |
| ZIP | 18940 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Aug 22, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 415706 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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