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1157266

Tower Laboratories Ltd. — FEI 1823985

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Montague, MI (United States)

Facility

Other inspections at this facility

  • 1088216 (VAI Thu May 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050567 (VAI Wed May 02 2018 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
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
2129521 CFR 211.110(b)In-process conformity - examination, sample testing
360321 CFR 211.160(b)Scientifically sound laboratory controls