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998476

Carlsbad Technology, Inc — FEI 1000135190

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 4, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carlsbad, CA (United States)

Facility

Other inspections at this facility

  • 1156000 (VAI Fri Nov 05 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109660 (VAI Fri Oct 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100924 (NAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904879 (NAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753900 (NAI Thu Nov 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs