FDA inspection
Ambu Sdn. Bhd.: FDA inspection ending Apr 15, 2016
FDA inspection 967208 · Voluntary Action Indicated (VAI) · Penang
Key facts
| Inspection ID | 967208 |
|---|---|
| Firm | Ambu Sdn. Bhd. |
| FEI number | 3004040397 |
| Address | Lot 159, Jalan Sungei Keluang,, Bayan Lepas FIZ, PH. 1 |
| City | Penang |
| Country | Malaysia |
| Fiscal year | 2016 |
| Inspection end date | Apr 15, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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