FDA inspection
KEN Hygiene Systems A/S: FDA inspection ending Jun 29, 2023
FDA inspection 1210365 · Voluntary Action Indicated (VAI) · Broby
Key facts
| Inspection ID | 1210365 |
|---|---|
| Firm | KEN Hygiene Systems A/S |
| FEI number | 3008344687 |
| Address | Bogebjergvej 60 |
| City | Broby |
| Country | Denmark |
| Fiscal year | 2023 |
| Inspection end date | Jun 29, 2023 |
| 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