FDA Inspection
Topcon Medical Systems, Inc.FDA Inspection 1263711 - Topcon Medical Systems, Inc. - March 14, 2025
Record Details
This FDA Inspection record concerns Topcon Medical Systems, Inc., with an inspection on March 14, 2025, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- Topcon Medical Systems, Inc.
- Inspection Date
- March 14, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8b791e13-309f-4d7e-bc66-e263c2e8d759
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263711
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Topcon Medical Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
Other documents for Topcon Medical Systems, Inc.
- FDA Inspection 910566 - 2015-01-20
- FDA Inspection 883598 - 2014-06-16
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