FDA inspection
Polarean Inc: FDA inspection ending Sep 7, 2021
FDA inspection 1151036 · Official Action Indicated (OAI) · Durham, NC
Key facts
| Inspection ID | 1151036 |
|---|---|
| Firm | Polarean Inc |
| FEI number | 3010132318 |
| Address | 2500 Meridian Pkwy Ste 175 |
| City | Durham |
| State | NC |
| ZIP | 27713-4214 |
| Fiscal year | 2021 |
| Inspection end date | Sep 7, 2021 |
| Classification | Official Action Indicated (OAI) |
| 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