FDA inspection
Boston Scientific Medical Device (Malaysia) Sdn. Bhd.: FDA inspection ending May 22, 2026
FDA inspection 1318514 · Seberang Perai Selatan
Key facts
| Inspection ID | 1318514 |
|---|---|
| Firm | Boston Scientific Medical Device (Malaysia) Sdn. Bhd. |
| FEI number | 3014222368 |
| Address | Pmt 741, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan |
| City | Seberang Perai Selatan |
| Fiscal year | 2026 |
| Inspection end date | May 22, 2026 |
| Product type | Devices |
At a glance
- 1–9 Citations
- None 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