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1152900

Tender Corporation — FEI 1250045

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 23, 2021
Fiscal Year
2021
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
113621 CFR 211.25(c)Inadequate number of personnel
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
240621 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
438921 CFR 211.198(a)Procedures to be written and followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews