FDA inspection
The Hygenic Corporation: FDA inspection ending Dec 18, 2015
FDA inspection 953650 · Voluntary Action Indicated (VAI) · Batu Gajah
Key facts
| Inspection ID | 953650 |
|---|---|
| Firm | The Hygenic Corporation |
| FEI number | 3003123739 |
| Address | Plot 6, Persiaran Bemban |
| City | Batu Gajah |
| Country | Malaysia |
| Fiscal year | 2016 |
| Inspection end date | Dec 18, 2015 |
| 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