FDA inspection
Plaxtron Industrial (M) SDN. BHD.: FDA inspection ending Aug 15, 2024
FDA inspection 1247574 · Official Action Indicated (OAI) · Ipoh
Key facts
| Inspection ID | 1247574 |
|---|---|
| Firm | Plaxtron Industrial (M) SDN. BHD. |
| FEI number | 1000283452 |
| Address | Plot 28 Kawasan Perusahaan, Jelapang 2, Ftz |
| City | Ipoh |
| Country | Malaysia |
| Fiscal year | 2024 |
| Inspection end date | Aug 15, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: 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