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1204375

Tender Corporation — FEI 1250045

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Littleton, NH (United States)

Facility

Other inspections at this facility

  • 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))
  • 1055369 (VAI Thu Jun 07 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
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
182321 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
183321 CFR 211.84(d)(1)Identity Testing of Each Component