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816511

AIAC International Pharma, LLC — FEI 3011580268

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 24, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Arecibo, PR (United States)

Facility

Other inspections at this facility

  • 1139926 (NAI Tue Mar 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053879 (VAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939246 (VAI Mon Aug 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 720657 (VAI Thu Apr 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697792 (VAI Wed Nov 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
191421 CFR 211.166(a)Lack of written stability program
203121 CFR 211.194(a)Complete test data included in records