FDA Inspection
Olympus Medical Systems CorporationOlympus Medical Systems Corporation – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns Olympus Medical Systems Corporation, with an inspection on November 21, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- November 21, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 69069df6-8e59-4795-bd7e-02b224898c29
Inspection Facts
- Inspection number
- 1292170
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Olympus Medical Systems Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 24, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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