FDA inspection
Covidien: FDA inspection ending Apr 28, 2022
FDA inspection 1169814 · Official Action Indicated (OAI) · San Isidro
Key facts
| Inspection ID | 1169814 |
|---|---|
| Firm | Covidien |
| FEI number | 3003495548 |
| Address | Autopista San Isidro Km 17, Zona Franca De San Isidro |
| City | San Isidro |
| Country | Dominican Republic (the) |
| Fiscal year | 2022 |
| Inspection end date | Apr 28, 2022 |
| Classification | Official Action Indicated (OAI) |
| 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