FDA Inspection
Olympus Medical Systems CorporationOlympus Medical Systems Corporation – FDA Inspection, Sep 9, 2022
Record Details
This FDA Inspection record concerns Olympus Medical Systems Corporation, with an inspection on September 9, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 9, 2022
- Product Type
- Devices
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ID · 6b718265-ac91-491e-a19f-27c3467d3fe3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1179320
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Olympus Medical Systems Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| April 24, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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