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1050567

Tower Laboratories Ltd. — FEI 1823985

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 2, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Montague, MI (United States)

Facility

Other inspections at this facility

  • 1157266 (VAI Wed Nov 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088216 (VAI Thu May 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889886 (VAI Wed Jul 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 774283 (VAI Wed Mar 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 665293 (VAI Wed May 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
202821 CFR 211.192Extent of discrepancy, failure investigations
357721 CFR 211.101(b)(4)Subdivided component/container/finished drug
360321 CFR 211.160(b)Scientifically sound laboratory controls