FDA Inspection
SEKO MedTec SolutionsSEKO MedTec Solutions – FDA Inspection, Nov 8, 2019
Record Details
This FDA Inspection record concerns SEKO MedTec Solutions, with an inspection on November 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SEKO MedTec Solutions
- Inspection Date
- November 8, 2019
- Product Type
- Devices
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ID · d48bb3cb-241a-473b-8466-dfdbb2c88917
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109811
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of SEKO MedTec Solutions
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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