Company
JapanOlympus Medical Systems Corporation, Hachioji, Japan – FDA Inspections
Inspection records and compliance data for Olympus Medical Systems Corporation in Hachioji. 3 FDA inspections on record (2 OAI), 1 Form 483, 2 warning letters, last inspected November 21, 2025.
Company Profile
This profile covers Olympus Medical Systems Corporation based in Hachioji, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 2
First inspected April 24, 2015. Last inspected November 21, 2025.
Most cited issue areas
- Report of Death or Serious Injury2 inspections
- Design control - no procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1292170 |
| September 9, 2022 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1179320 |
| April 24, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 926218 |
FDA documents
Warning Letters (2)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Olympus Medical Systems Corporation
FEI Number
3002807795
Address
Orinpasukogakukogyo (Kabu) Gijutsukaihatsusentaishikawa, 2951; Ishikawa-Machi, Hachioji, Japan
Country
Japan
ID: 85e505c8-f012-4c6c-bce6-67e3879f0d01