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1279218

HTO Nevada Inc. dba Kirkman — FEI 3004268965

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 22, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lake Oswego, OR (United States)

Facility

Other inspections at this facility

  • 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))
  • 935663 (NAI Wed Jul 15 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
136121 CFR 211.100(a)Absence of Written Procedures
149821 CFR 211.122(b)Labeling and packaging improperly approved/released
176821 CFR 211.137(b)Storage conditions
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
439121 CFR 211.180(e)(2)Items to cover on annual reviews