FDA inspection
Bioporto Diagnostics: FDA inspection ending Sep 13, 2018
FDA inspection 1131714 · Voluntary Action Indicated (VAI) · Hellerup
Key facts
| Inspection ID | 1131714 |
|---|---|
| Firm | Bioporto Diagnostics |
| FEI number | 3010739981 |
| Address | Tuborg Havnevej 15, St |
| City | Hellerup |
| Fiscal year | 2018 |
| Inspection end date | Sep 13, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical 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