FDA Inspection
DK MEDICAL SYSTEMS CO., LTD.DK MEDICAL SYSTEMS CO., LTD. – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns DK MEDICAL SYSTEMS CO., LTD., with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- DK MEDICAL SYSTEMS CO., LTD.
- Inspection Date
- September 17, 2026
- Product Type
- Medical Devices & Rad Health
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ID · a4455728-4489-40b2-b195-6d37681505a7
Inspection Facts
- Inspection number
- 1335994
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of DK MEDICAL SYSTEMS CO., LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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