FDA inspection
Orthana Kemisk Fabrik A/S: FDA inspection ending Sep 23, 2022
FDA inspection 1187265 · Voluntary Action Indicated (VAI) · Kastrup
Key facts
| Inspection ID | 1187265 |
|---|---|
| Firm | Orthana Kemisk Fabrik A/S |
| FEI number | 1000248695 |
| Address | Englandsvej 350-356 |
| City | Kastrup |
| Country | Denmark |
| Fiscal year | 2022 |
| Inspection end date | Sep 23, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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