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738728

Advanced Generic Corporation — FEI 3009054145

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 1, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1067077 (NAI Mon Jul 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925397 (NAI Thu May 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769040 (NAI Mon Feb 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113421 CFR 211.25(b)Supervisor Training/Education/Experience
1540221 CFR 111.12Personnel - quality control personnel - qualified
1592721 CFR 111.103Written procedures - quality control operations
1592821 CFR 111.103Written procedure quality control operations material review
256721 CFR 211.198(a)Adverse Drug Experience