FDA inspection
Monarch Labs, LLC: FDA inspection ending Feb 13, 2024
FDA inspection 1233686 · No Action Indicated (NAI) · Irvine, CA
Key facts
| Inspection ID | 1233686 |
|---|---|
| Firm | Monarch Labs, LLC |
| FEI number | 3005735989 |
| Address | 17875 Sky Park Cir Ste K |
| City | Irvine |
| State | CA |
| ZIP | 92614-6114 |
| Fiscal year | 2024 |
| Inspection end date | Feb 13, 2024 |
| 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
- 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