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753900

Carlsbad Technology, Inc — FEI 1000135190

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 17, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Postmarket Surv. and Epidemiology
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))
  • 998476 (VAI Fri Nov 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904879 (NAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
144921 CFR 211.111Deviations of production time limits
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358321 CFR 211.110(a)Written in-process control procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies