FDA Inspection
DK MEDICAL SYSTEMS CO., LTD.DK MEDICAL SYSTEMS CO., LTD. – FDA Inspection, Nov 2, 2023
Record Details
This FDA Inspection record concerns DK MEDICAL SYSTEMS CO., LTD., with an inspection on November 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9bc1a502-c070-4800-9a88-12f1b1a07b02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223665
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of DK MEDICAL SYSTEMS CO., LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2026 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
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