FDA inspection
Criticare Systems (Malaysia) Sdn. Bhd.: FDA inspection ending Sep 19, 2014
FDA inspection 899521 · Official Action Indicated (OAI) · Nusajaya
Key facts
| Inspection ID | 899521 |
|---|---|
| Firm | Criticare Systems (Malaysia) Sdn. Bhd. |
| FEI number | 3008727514 |
| Address | No. 19 Jalan Mega 1/8, Taman Perindustrian Nusa Cemerlang |
| City | Nusajaya |
| Country | Malaysia |
| Fiscal year | 2014 |
| Inspection end date | Sep 19, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 445485 |
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