FDA inspection
OPULENT SOLUTIONS SDN BHD: FDA inspection ending May 17, 2023
FDA inspection 1205503 · Voluntary Action Indicated (VAI) · Bayan Lepas
Key facts
| Inspection ID | 1205503 |
|---|---|
| Firm | OPULENT SOLUTIONS SDN BHD |
| FEI number | 3013387006 |
| Address | Plot 111 Bayan Lepas Industrial Park, Lebuh Raya |
| City | Bayan Lepas |
| Country | Malaysia |
| Fiscal year | 2023 |
| Inspection end date | May 17, 2023 |
| 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