FDA Inspection
Denka Co. Ltd.Denka Co. Ltd. – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns Denka Co. Ltd., with an inspection on September 3, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · fabaa182-09d0-4628-9d34-6c9b0cec92e7
Inspection Facts
- Inspection number
- 1335070
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
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Other FDA inspections of Denka Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Denka Co. Ltd.
- FDA Inspection 1241642 - 2024-05-23
- FDA Inspection 1022352 - 2017-07-06
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