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744287

Iso-Tex Diagnostics, Inc. — FEI 1626310

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 12, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alvin, TX (United States)

Facility

Other inspections at this facility

  • 1197186 (OAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118892 (NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065390 (NAI Wed Aug 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039153 (VAI Wed Jan 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934315 (OAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126121 CFR 211.68(a)Written calibration / inspection records not kept
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products