FDA inspection
Merit Medical Ireland Ltd.: FDA inspection ending Sep 15, 2011
FDA inspection 748653 · Official Action Indicated (OAI) · Galway
Key facts
| Inspection ID | 748653 |
|---|---|
| Firm | Merit Medical Ireland Ltd. |
| FEI number | 3000335778 |
| Address | Parkmore Industrial Estate |
| City | Galway |
| Country | Ireland |
| Fiscal year | 2011 |
| Inspection end date | Sep 15, 2011 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 236954 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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