FDA inspection
Cordis LLC: FDA inspection ending Oct 13, 2010
FDA inspection 685359 · Official Action Indicated (OAI) · San German, PR
Key facts
| Inspection ID | 685359 |
|---|---|
| Firm | Cordis LLC |
| FEI number | 3003742446 |
| Address | Road 362, Km,0.5 |
| City | San German |
| State | PR |
| ZIP | 00683 |
| Country | United States |
| Fiscal year | 2011 |
| Inspection end date | Oct 13, 2010 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 163132 |
At a glance
- 1–9 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