FDA inspection
Medtronic Puerto Rico Operations Co.: FDA inspection ending May 15, 2018
FDA inspection 1052808 · Official Action Indicated (OAI) · Juncos, PR
Key facts
| Inspection ID | 1052808 |
|---|---|
| Firm | Medtronic Puerto Rico Operations Co. |
| FEI number | 3004369318 |
| Address | Ceiba Norte Industrial Park, 50 Road 31 Km 24.4 |
| City | Juncos |
| State | PR |
| ZIP | 00777 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | May 15, 2018 |
| Classification | Official Action Indicated (OAI) |
| Project area | Project Evaluation: Devices |
| Product type | Devices |
| Warning letter | 562437 |
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
- 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