Home / Inspections / 664030

664030

Iso-Tex Diagnostics, Inc. — FEI 1626310

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 2, 2010
Fiscal Year
2010
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
119421 CFR 211.42(c)Defined areas of adequate size for operations
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
354721 CFR 211.46(b)Equipment for Environmental Control
356121 CFR 211.56(b)Written sanitation procedures lacking
430221 CFR 211.56(b)Written sanitation procedures not followed