FDA inspection
SYSMEX CORPORATION I-SQUARE: FDA inspection ending Sep 16, 2016
FDA inspection 990227 · Voluntary Action Indicated (VAI) · Kakogawa
Key facts
| Inspection ID | 990227 |
|---|---|
| Firm | SYSMEX CORPORATION I-SQUARE |
| FEI number | 3010960914 |
| Address | Mizuashi 262-11, Noguchi-Cho |
| City | Kakogawa |
| Country | Japan |
| Fiscal year | 2016 |
| Inspection end date | Sep 16, 2016 |
| 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
- 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