1063111

Biotex Inc. — FEI 3005726841

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 23, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Houston, TX (United States)

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures