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754549

Quantum Analytics Group Inc. — FEI 3010166238

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 14, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monmouth Junction, NJ (United States)

Facility

Other inspections at this facility

  • 1276690 (NAI Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131461 (NAI Wed Sep 02 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918491 (VAI Thu Mar 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812252 (VAI Fri Dec 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 698928 (VAI Wed Nov 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
117721 CFR 211.63Equipment Design, Size and Location
180921 CFR 211.160(a)Following/documenting laboratory controls
203121 CFR 211.194(a)Complete test data included in records
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440621 CFR 211.194(a)(2)Suitability of testing methods verified