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799707

Quest Diagnostics — FEI 1872752

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1245312 (NAI Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069321 (NAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983437 (VAI Thu Aug 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889102 (VAI Mon Jul 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 681842 (VAI Wed Sep 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15921 CFR 606.160(a)(1)Legibility and indelibility
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration