FDA inspection
Qualgen, LLC: FDA inspection ending May 10, 2017
FDA inspection 1014041 · Official Action Indicated (OAI) · Edmond, OK
Key facts
| Inspection ID | 1014041 |
|---|---|
| Firm | Qualgen, LLC |
| FEI number | 3011286349 |
| Address | 14844 Bristol Park Blvd |
| City | Edmond |
| State | OK |
| ZIP | 73013 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | May 10, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 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