FDA inspection
Bioasia Worldwide Sdn Bhd: FDA inspection ending Oct 17, 2024
FDA inspection 1252128 · Official Action Indicated (OAI) · Sitiawan
Key facts
| Inspection ID | 1252128 |
|---|---|
| Firm | Bioasia Worldwide Sdn Bhd |
| FEI number | 3015509166 |
| Address | U-11 Lumut Port Industrial Park |
| City | Sitiawan |
| Country | Malaysia |
| Fiscal year | 2025 |
| Inspection end date | Oct 17, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 700093 |
At a glance
- 10–99 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