FDA inspection
OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant: FDA inspection ending Nov 10, 2022
FDA inspection 1191683 · Official Action Indicated (OAI) · Nishitama-Gun
Key facts
| Inspection ID | 1191683 |
|---|---|
| Firm | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant |
| FEI number | 3003637092 |
| Address | 34-3 Hirai, Hinode-machi |
| City | Nishitama-Gun |
| Country | Japan |
| Fiscal year | 2023 |
| Inspection end date | Nov 10, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 654013 |
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