FDA inspection
OraLabs LLC: FDA inspection ending May 28, 2019
FDA inspection 1090928 · Voluntary Action Indicated (VAI) · Parker, CO
Key facts
| Inspection ID | 1090928 |
|---|---|
| Firm | OraLabs LLC |
| FEI number | 3001237145 |
| Address | 18685 Plaza Dr |
| City | Parker |
| State | CO |
| ZIP | 80134 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | May 28, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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