941391

GeoTec, Inc. — FEI 1000120768

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 24, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Warwick, RI (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
1472221 CFR 820.40Procedures not adequately established or maintained
333121 CFR 820.181DMR - not or inadequately maintained
369621 CFR 820.100(b)Documentation
54621 CFR 820.75(a)Lack of or inadequate process validation