FDA inspection
TYTEX SLOVAKIA S.R.O.: FDA inspection ending Jan 24, 2013
FDA inspection 818779 · Official Action Indicated (OAI) · Humenne
Key facts
| Inspection ID | 818779 |
|---|---|
| Firm | TYTEX SLOVAKIA S.R.O. |
| FEI number | 3006121457 |
| Address | Chemlonska 1 |
| City | Humenne |
| Country | Slovakia |
| Fiscal year | 2013 |
| Inspection end date | Jan 24, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 395556 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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