FDA inspection
SK Biotek Ireland Ltd.: FDA inspection ending Nov 3, 2017
FDA inspection 1035255 · Voluntary Action Indicated (VAI) · Swords
Key facts
| Inspection ID | 1035255 |
|---|---|
| Firm | SK Biotek Ireland Ltd. |
| FEI number | 3002806583 |
| Address | Watery Lane |
| City | Swords |
| Country | Ireland |
| Fiscal year | 2018 |
| Inspection end date | Nov 3, 2017 |
| 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
- No Establishment inspection report (EIR) exists
- 10–99 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