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810516

Ascent Pharmaceuticals Inc — FEI 3009518416

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Central Islip, NY (United States)

Facility

Other inspections at this facility

  • 1229681 (VAI Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179615 (VAI Thu Sep 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1132410 (VAI Tue Oct 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074882 (NAI Wed Nov 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067030 (NAI Fri Jul 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
355721 CFR 211.52Washing and toilet facilities are deficient
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly