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981581

Microbiological Testing & Consulting, LLC — FEI 3003875820

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alsip, IL (United States)

Facility

Other inspections at this facility

  • 1043555 (VAI Thu Mar 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729858 (VAI Tue Jun 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 648686 (VAI Wed Feb 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
188521 CFR 211.165(b)Microbiological testing
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action