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1149069

Water-Jel Technologies, LLC — FEI 1219592

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 18, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Huntersville, NC (United States)

Facility

Other inspections at this facility

  • 1099591 (VAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026705 (VAI Wed Sep 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992245 (VAI Fri Nov 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900118 (VAI Fri Oct 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799336 (VAI Wed Sep 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation
430521 CFR 211.68(b)Backup data not assured as exact and complete
54621 CFR 820.75(a)Lack of or inadequate process validation