FDA inspection
Karex Industries Sdn Bhd: FDA inspection ending Apr 19, 2012
FDA inspection 782301 · Voluntary Action Indicated (VAI) · Pontian
Key facts
| Inspection ID | 782301 |
|---|---|
| Firm | Karex Industries Sdn Bhd |
| FEI number | 1000535235 |
| Address | Ptd 7906 & 7907, Taman Pontian Jaya, Batu 34 |
| City | Pontian |
| Country | Malaysia |
| Fiscal year | 2012 |
| Inspection end date | Apr 19, 2012 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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