FDA inspection
Polarean Inc: FDA inspection ending Aug 19, 2022
FDA inspection 1177976 · Voluntary Action Indicated (VAI) · Durham, NC
Key facts
| Inspection ID | 1177976 |
|---|---|
| Firm | Polarean Inc |
| FEI number | 3010132318 |
| Address | 2500 Meridian Pkwy Ste 175 |
| City | Durham |
| State | NC |
| ZIP | 27713-4214 |
| Fiscal year | 2022 |
| Inspection end date | Aug 19, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | New Drug Evaluation |
| 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