FDA inspection
Optikem International, Inc.: FDA inspection ending Jan 26, 2024
FDA inspection 1227815 · Official Action Indicated (OAI) · Denver, CO
Key facts
| Inspection ID | 1227815 |
|---|---|
| Firm | Optikem International, Inc. |
| FEI number | 1720129 |
| Address | 2172 S Jason St |
| City | Denver |
| State | CO |
| ZIP | 80227 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Jan 26, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 680264 |
At a glance
- 10–99 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