FDA Inspection
MedTek Skin Care, Inc. d/b/a UVBiotekMedTek Skin Care, Inc. d/b/a UVBiotek – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns MedTek Skin Care, Inc. d/b/a UVBiotek, with an inspection on July 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 38e656ee-2731-4e18-becc-533c58166334
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060031
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 1040.20(f)Test deficiencies
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Other FDA inspections of MedTek Skin Care, Inc. d/b/a UVBiotek
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for MedTek Skin Care, Inc. d/b/a UVBiotek
- FDA Inspection 1171909 - 2022-06-10
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