871514

DermaMed Solutions, LLC — FEI 3002683172

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 5, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Lenni, PA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
317221 CFR 820.198(c)Investigation of device failures
341521 CFR 820.22Quality Audit/Reaudit - conducted
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency