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1117380

PTI Georgia, LLC — FEI 3005372036

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 6, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Royston, GA (United States)

Facility

Other inspections at this facility

  • 1037509 (VAI Thu Jan 11 2018 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
180921 CFR 211.160(a)Following/documenting laboratory controls
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews