FDA inspection
St. Jude Medical Puerto Rico LLC: FDA inspection ending Oct 12, 2019
FDA inspection 1121010 · No Action Indicated (NAI) · Arecibo, PR
Key facts
| Inspection ID | 1121010 |
|---|---|
| Firm | St. Jude Medical Puerto Rico LLC |
| FEI number | 3006705815 |
| Address | Lot A Interior -Carr #2 Km 67.5, Santana Indl. Park, Sector Los Pinos |
| City | Arecibo |
| State | PR |
| ZIP | 00613-6025 |
| Fiscal year | 2020 |
| Inspection end date | Oct 12, 2019 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None 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