FDA inspection
Monarch Labs, LLC: FDA inspection ending Jun 14, 2010
FDA inspection 666555 · Official Action Indicated (OAI) · Irvine, CA
Key facts
| Inspection ID | 666555 |
|---|---|
| Firm | Monarch Labs, LLC |
| FEI number | 3005735989 |
| Address | 17875 Sky Park Cir Ste K |
| City | Irvine |
| State | CA |
| ZIP | 92614 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Jun 14, 2010 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 120768 |
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