FDA inspection
Ortho Solutions Sdn. Bhd.: FDA inspection ending May 16, 2024
FDA inspection 1240298 · Voluntary Action Indicated (VAI) · Prai
Key facts
| Inspection ID | 1240298 |
|---|---|
| Firm | Ortho Solutions Sdn. Bhd. |
| FEI number | 3012755988 |
| Address | 2821, Tingkat Perusahaan 5a, Prai Industrial Estate |
| City | Prai |
| Country | Malaysia |
| Fiscal year | 2024 |
| Inspection end date | May 16, 2024 |
| 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