FDA inspection
Heliora Laboratories Pty Ltd.: FDA inspection ending May 31, 2019
FDA inspection 1091244 · Official Action Indicated (OAI) · Osborne Park
Key facts
| Inspection ID | 1091244 |
|---|---|
| Firm | Heliora Laboratories Pty Ltd. |
| FEI number | 3006210769 |
| Address | 2 Action Road |
| City | Osborne Park |
| Country | Australia |
| Fiscal year | 2019 |
| Inspection end date | May 31, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 589463 |
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
- 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