FDA inspection
Biocartis Nv: FDA inspection ending Dec 1, 2017
FDA inspection 1045812 · No Action Indicated (NAI) · Mechelen
Key facts
| Inspection ID | 1045812 |
|---|---|
| Firm | Biocartis Nv |
| FEI number | 3009972873 |
| Address | B 3, Generaal De Wittelaan 11 |
| City | Mechelen |
| Fiscal year | 2018 |
| Inspection end date | Dec 1, 2017 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None 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