FDA inspection
OEM Systems Co. Ltd.: FDA inspection ending Oct 28, 2010
FDA inspection 699130 · Official Action Indicated (OAI) · Uji
Key facts
| Inspection ID | 699130 |
|---|---|
| Firm | OEM Systems Co. Ltd. |
| FEI number | 1000487132 |
| Address | Megawa 84, Makishima-Cho |
| City | Uji |
| Country | Japan |
| Fiscal year | 2011 |
| Inspection end date | Oct 28, 2010 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 156054 |
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