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1037509

PTI Georgia, LLC — FEI 3005372036

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 11, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Royston, GA (United States)

Facility

Other inspections at this facility

  • 1117380 (VAI Thu Feb 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 905455 (VAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 717080 (NAI Fri Mar 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 543588 (NAI Fri Oct 17 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action