FDA inspection
ITL Asia Pacific Sdn Bhd: FDA inspection ending May 30, 2019
FDA inspection 1093574 · Official Action Indicated (OAI) · Batu Gajah
Key facts
| Inspection ID | 1093574 |
|---|---|
| Firm | ITL Asia Pacific Sdn Bhd |
| FEI number | 3011649541 |
| Address | Plot 17b, Lorong Bemban 2, Bemban Industrial Estate |
| City | Batu Gajah |
| Country | Malaysia |
| Fiscal year | 2019 |
| Inspection end date | May 30, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 590380 |
At a glance
- None 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