1147072

Atalys Asheboro LLC — FEI 1000111291

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 23, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Asheboro, NC (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
369621 CFR 820.100(b)Documentation
63021 CFR 803.17Lack of Written MDR Procedures