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1197186

Iso-Tex Diagnostics, Inc. — FEI 1626310

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 10, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alvin, TX (United States)

Facility

Other inspections at this facility

  • 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))
  • 893916 (NAI Wed Aug 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
355721 CFR 211.52Washing and toilet facilities are deficient
361321 CFR 211.160(b)(4)Establishment of calibration procedures