FDA inspection
Orthorebirth Co Ltd: FDA inspection ending Sep 22, 2025
FDA inspection 1286314 · Official Action Indicated (OAI) · Yokohama
Key facts
| Inspection ID | 1286314 |
|---|---|
| Firm | Orthorebirth Co Ltd |
| FEI number | 3011415547 |
| Address | 3 Chome 17-43, Chigasakihigashi; Tsuzuki |
| City | Yokohama |
| Country | Japan |
| Fiscal year | 2025 |
| Inspection end date | Sep 22, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- None 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