Home / Inspections / 697792

697792

AIAC International Pharma, LLC — FEI 3011580268

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 3, 2010
Fiscal Year
2011
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))
  • 816511 (VAI Thu Jan 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 720657 (VAI Thu Apr 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126121 CFR 211.68(a)Written calibration / inspection records not kept
180921 CFR 211.160(a)Following/documenting laboratory controls
241921 CFR 211.198(a)Complaint Handling Procedure