FDA inspection
Ambu Sdn. Bhd.: FDA inspection ending Sep 19, 2013
FDA inspection 853156 · Voluntary Action Indicated (VAI) · Penang
Key facts
| Inspection ID | 853156 |
|---|---|
| Firm | Ambu Sdn. Bhd. |
| FEI number | 3004040397 |
| Address | Lot 69-B, Lintang Bayan Lepas 6, Phase Iv |
| City | Penang |
| Country | Malaysia |
| Fiscal year | 2013 |
| Inspection end date | Sep 19, 2013 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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