FDA inspection
Hitachi High Tech America, Inc. Radiation Therapy Division: FDA inspection ending Mar 4, 2022
FDA inspection 1164083 · Voluntary Action Indicated (VAI) · Santa Clara, CA
Key facts
| Inspection ID | 1164083 |
|---|---|
| Firm | Hitachi High Tech America, Inc. Radiation Therapy Division |
| FEI number | 3003993895 |
| Address | 707 Westchester Ave Ste Ll07 |
| City | Santa Clara |
| State | CA |
| ZIP | 95054 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Mar 4, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Radiation Control and Health Safety Act |
| 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