FDA inspection
Polynovo Biomaterials Pty Ltd.: FDA inspection ending Oct 19, 2017
FDA inspection 1029183 · Voluntary Action Indicated (VAI) · Port Melbourne
Key facts
| Inspection ID | 1029183 |
|---|---|
| Firm | Polynovo Biomaterials Pty Ltd. |
| FEI number | 3007886187 |
| Address | U 2 320 Lorimer St |
| City | Port Melbourne |
| Country | Australia |
| Fiscal year | 2018 |
| Inspection end date | Oct 19, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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