1214471

SM ENG. Co. Ltd. — FEI 3008912461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 21, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Sasang (Korea (the Republic of))

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
54621 CFR 820.75(a)Lack of or inadequate process validation