FDA Inspection
Topcon Yamagata Co., Ltd.Topcon Yamagata Co., Ltd. – FDA Inspection, Feb 20, 2014
Record Details
This FDA Inspection record concerns Topcon Yamagata Co., Ltd., with an inspection on February 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Topcon Yamagata Co., Ltd.
- Inspection Date
- February 20, 2014
- Product Type
- Devices
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ID · cc4c1f6b-a074-492b-990e-c9514d2f3dde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868121
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Topcon Yamagata Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Topcon Yamagata Co., Ltd.
- FDA Inspection 1083418 - 2019-02-15
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