FDA Inspection
SEKO MedTec SolutionsSEKO MedTec Solutions – FDA Inspection, Jul 8, 2024
Record Details
This FDA Inspection record concerns SEKO MedTec Solutions, with an inspection on July 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8f7f7d87-0dc8-4183-93e3-cb8446966bc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243315
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.120(a)Remain legible
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of SEKO MedTec Solutions
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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