FDA inspection
Dextrum Laboratories: FDA inspection ending Jul 18, 2023
FDA inspection 1210295 · Official Action Indicated (OAI) · Miami, FL
Key facts
| Inspection ID | 1210295 |
|---|---|
| Firm | Dextrum Laboratories |
| FEI number | 3003092372 |
| Address | 6993 Nw 82nd Ave Ste 20 |
| City | Miami |
| State | FL |
| ZIP | 33166 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Jul 18, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 666442 |
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
- 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