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1043555

Microbiological Testing & Consulting, LLC — FEI 3003875820

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alsip, IL (United States)

Facility

Other inspections at this facility

  • 981581 (VAI Wed Jul 27 2016 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
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
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action