FDA inspection
CoRE labs, LLC: FDA inspection ending Jul 25, 2012
FDA inspection 791995 · Official Action Indicated (OAI) · Englewood, CO
Key facts
| Inspection ID | 791995 |
|---|---|
| Firm | CoRE labs, LLC |
| FEI number | 3001620005 |
| Address | 3720 S Lipan St |
| City | Englewood |
| State | CO |
| ZIP | 80110 |
| Country | United States |
| Fiscal year | 2012 |
| Inspection end date | Jul 25, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 343219 |
At a glance
- None 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