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834739

Tower Laboratories, Ltd. — FEI 1219540

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Centerbrook, CT (United States)

Facility

Other inspections at this facility

  • 1264996 (VAI Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167686 (NAI Mon Apr 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046208 (VAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983675 (NAI Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773285 (NAI Thu Mar 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
145421 CFR 211.115(a)Reprocessing procedures not written or followed
1570221 CFR 111.320(b)Examination, testing; scientifically valid
1588521 CFR 111.77(a)Specifications not met - reject, quality control
181021 CFR 211.160(a)Lab controls established, including changes
189021 CFR 211.165(e)Test methods
358821 CFR 211.110(a)(3)Mixing adequacy