Home / Inspections / 933396

933396

HTO Nevada Inc. dba Kirkman — FEI 3004268965

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 24, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lake Oswego, OR (United States)

Facility

Other inspections at this facility

  • 1279218 (OAI Fri Aug 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216435 (VAI Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083505 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065834 (NAI Mon Apr 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010178 (VAI Fri Apr 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145021 CFR 211.113(a)Procedures for non-sterile drug products
154021 CFR 211.125(a)Strict control not exercised over labeling issued
162621 CFR 211.130Procedures are written, and followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete