FDA inspection
Sirtex Singapore Manufacturing Pte Ltd: FDA inspection ending Oct 3, 2018
FDA inspection 1122618 · No Action Indicated (NAI) · Singapore
Key facts
| Inspection ID | 1122618 |
|---|---|
| Firm | Sirtex Singapore Manufacturing Pte Ltd |
| FEI number | 3009088444 |
| Address | 50 Science Park Road, The Kendall |
| City | Singapore |
| Fiscal year | 2019 |
| Inspection end date | Oct 3, 2018 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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