FDA inspection
Berlin Heart Inc: FDA inspection ending Jul 2, 2025
FDA inspection 1274495 · Voluntary Action Indicated (VAI) · The Woodlands, TX
Key facts
| Inspection ID | 1274495 |
|---|---|
| Firm | Berlin Heart Inc |
| FEI number | 3008454189 |
| Address | 9391 Grogans Mill Rd Ste A6 |
| City | The Woodlands |
| State | TX |
| ZIP | 77380-3628 |
| Fiscal year | 2025 |
| Inspection end date | Jul 2, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Medical 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