Company
United StatesTopcon Medical Systems, Inc. - Inspection Records
Inspection records and compliance data for Topcon Medical Systems, Inc. in Oakland, New Jersey. 3 FDA inspections on record, 1 Form 483, last inspected March 14, 2025.
Company Profile
This profile covers Topcon Medical Systems, Inc. based in Oakland, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 16, 2014. Last inspected March 14, 2025.
Most cited issue areas
- Complaints1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2025 | VAI | New Jersey District Office | Compliance: Medical Devices |
| January 20, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Documents (5)
FDA Inspection 1263711 - Topcon Medical Systems, Inc. - 2025-03-14
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FDA Inspection 1263711 - Topcon Medical Systems, Inc. - 2025-03-14
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FDA Inspection 910566 - Topcon Medical Systems, Inc. - 2015-01-20
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FDA Inspection 883598 - Topcon Medical Systems, Inc. - 2014-06-16
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FDA Inspection 883598 - Topcon Medical Systems, Inc. - 2014-06-16
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Search nearby companiesCompany Information
Name
Topcon Medical Systems, Inc.
FEI Number
2242863
State
New Jersey
City
Oakland
ID: 04122a23-c21b-4557-aac0-72529e5b757b