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1055369

Tender Corporation — FEI 1250045

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 7, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Littleton, NH (United States)

Facility

Other inspections at this facility

  • 1204375 (VAI Wed Apr 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152900 (OAI Thu Sep 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1110927 (OAI Mon Nov 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1070292 (VAI Fri Oct 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 972357 (VAI Tue May 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures