FDA inspection
Sekisui Medical Co., Ltd.: FDA inspection ending Jun 17, 2016
FDA inspection 975168 · Official Action Indicated (OAI) · Hachimantai
Key facts
| Inspection ID | 975168 |
|---|---|
| Firm | Sekisui Medical Co., Ltd. |
| FEI number | 3002806840 |
| Address | Dai 4 Chiwari 115, Matsuo |
| City | Hachimantai |
| Country | Japan |
| Fiscal year | 2016 |
| Inspection end date | Jun 17, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 507037 |
At a glance
- None 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