927679

HertART ApS — FEI 3008524469

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 29, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Vastra Frolunda (Sweden)

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
369621 CFR 820.100(b)Documentation