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841998

HTO Nevada Inc. dba Kirkman — FEI 3004268965

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 6, 2013
Fiscal Year
2013
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
122721 CFR 211.67(c)Cleaning/maintenance records not kept
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
178721 CFR 211.80(a)Procedures To Be in Writing
180121 CFR 211.84(a)Components withheld from use pending release
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
359121 CFR 211.110(b)In-process materials specifications
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
437321 CFR 211.188(b)(7)Actual yield, % of theoretical yield
439121 CFR 211.180(e)(2)Items to cover on annual reviews
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.