FDA Inspection 1171909 — MedTek Skin Care, Inc.

MedTek Skin Care, Inc. — FEI 1318319

The FDA completed an inspection of MedTek Skin Care, Inc. on Jun 10, 2022 in Hudson Falls, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jun 10, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Hudson Falls, NY (United States)

Citations

IDCFRDescription
316821 CFR 820.198(a)Complaints
341521 CFR 820.22Quality Audit/Reaudit - conducted
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency