Topcon 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.
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
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 14, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1263711 |
| January 20, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 910566 |
| June 16, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 883598 |
No Form 483s, Warning Letters or EIRs on record.
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Name
Topcon Medical Systems, Inc.
FEI Number
2242863
Address
111 Bauer Dr, Oakland, New Jersey 07436, United States
Country
United States
ID: 04122a23-c21b-4557-aac0-72529e5b757b