FDA inspection
B-ONE ORTHO, CORP.: FDA inspection ending May 18, 2022
FDA inspection 1169753 · Voluntary Action Indicated (VAI) · Cedar Knolls, NJ
Key facts
| Inspection ID | 1169753 |
|---|---|
| Firm | B-ONE ORTHO, CORP. |
| FEI number | 3015259876 |
| Address | 3 Wing Dr Ste 259 |
| City | Cedar Knolls |
| State | NJ |
| ZIP | 07927 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | May 18, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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