FDA inspection
Innolatex Sdn. Bhd.: FDA inspection ending Jan 20, 2011
FDA inspection 709156 · Official Action Indicated (OAI) · Port Klang
Key facts
| Inspection ID | 709156 |
|---|---|
| Firm | Innolatex Sdn. Bhd. |
| FEI number | 3003117682 |
| Address | Lot 591 & 594, Pandamaran Industrial Estate, Persiaran Raja Lumu |
| City | Port Klang |
| Country | Malaysia |
| Fiscal year | 2011 |
| Inspection end date | Jan 20, 2011 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 179013 |
At a glance
- 1–9 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