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991571

Pace Analytical Life Sciences — FEI 3006500621

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 31, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salem, NH (United States)

Facility

Other inspections at this facility

  • 1103560 (NAI Thu Sep 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071111 (NAI Fri Oct 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904543 (NAI Wed Oct 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 816428 (NAI Thu Jan 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748704 (VAI Fri Oct 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
187921 CFR 211.180(c)Records not made readily available to FDA
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440221 CFR 211.192Written record of investigation incomplete