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972357

Tender Corporation — FEI 1250045

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
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))
  • 1055369 (VAI Thu Jun 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
180121 CFR 211.84(a)Components withheld from use pending release
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188321 CFR 211.165(a)Testing and release for distribution
191221 CFR 211.166(a)Written program not followed
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls