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653985

Water-Jel Technologies, LLC — FEI 1219592

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 26, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Huntersville, NC (United States)

Facility

Other inspections at this facility

  • 1149069 (VAI Wed Aug 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
126121 CFR 211.68(a)Written calibration / inspection records not kept
136121 CFR 211.100(a)Absence of Written Procedures
430321 CFR 211.67(b)Written procedures fail to include
457621 CFR 211.192No written record of investigation