Home / Inspections / 939246

939246

AIAC International Pharma, LLC — FEI 3011580268

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2015
Fiscal Year
2015
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))
  • 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))
  • 697792 (VAI Wed Nov 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122721 CFR 211.67(c)Cleaning/maintenance records not kept
139521 CFR 211.103Actual vs. theoretical yields not determined
202821 CFR 211.192Extent of discrepancy, failure investigations
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
360321 CFR 211.160(b)Scientifically sound laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions