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832691

Argenta US Manufacturing LLC — FEI 1910953

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 21, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Shawnee, KS (United States)

Facility

Other inspections at this facility

  • 1225274 (VAI Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1192756 (VAI Wed Dec 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098756 (VAI Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987003 (NAI Mon Aug 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936339 (VAI Thu Jul 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
162921 CFR 211.130(a)Prevention of cross contamination, mix-ups
203121 CFR 211.194(a)Complete test data included in records
430321 CFR 211.67(b)Written procedures fail to include
440621 CFR 211.194(a)(2)Suitability of testing methods verified