FDA Inspection
DENTIS Co., LTD Medical DivisionDENTIS Co., LTD Medical Division – FDA Inspection, Sep 10, 2026
Record Details
This FDA Inspection record concerns DENTIS Co., LTD Medical Division, with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 10, 2026
- Product Type
- Medical Devices & Rad Health
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ID · d1faab6c-8437-4528-a67a-edcb6f8da868
Inspection Facts
- Inspection number
- 1336240
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.3.6Design and development verification plans not documented
- ISO 13485:2016 Clause 7.6Records of equipment calibration and verification not maintained
- ISO 13485:2016 Clause 8.1Monitoring, measurement, analysis, and improvement processes not adequate
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Other FDA inspections of DENTIS Co., LTD Medical Division
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DENTIS Co., LTD Medical Division
- FDA Inspection 1229378 - 2024-01-25
- FDA Inspection 1036194 - 2017-11-16
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