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965451

Century Pharmaceuticals, Inc. — FEI 1819174

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1200075 (NAI Thu Feb 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1182259 (VAI Tue Oct 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042876 (NAI Thu Feb 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032039 (NAI Fri Aug 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863372 (NAI Tue Jan 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
144821 CFR 211.111Establishment of time limitations
145421 CFR 211.115(a)Reprocessing procedures not written or followed
361521 CFR 211.160(b)(4)Test devices not meeting specifications
435521 CFR 211.165(c)Sampling and testing plans not followed