FDA Inspection
Fuji Dynamics LimitedFuji Dynamics Limited – FDA Inspection, Mar 9, 2017
Record Details
This FDA Inspection record concerns Fuji Dynamics Limited, with an inspection on March 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Todd Q. Dang (Issuing Officer)
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ID · 9fd6a16c-d3fa-4078-bf72-4937ce11c910
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007160
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Fuji Dynamics Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2026 | Not classified | Office of Inspections and Investigations | |
| October 24, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fuji Dynamics Limited
- FDA Inspection 1317250 - 2026-04-23
- FDA Inspection 1110342 - 2019-10-24
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