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1083739

Dixon Investments Inc — FEI 1037559

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 22, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Orchard Hill, GA (United States)

Facility

Other inspections at this facility

  • 1263416 (OAI Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956550 (VAI Wed Dec 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858354 (VAI Fri Dec 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 758691 (VAI Tue Dec 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 646629 (VAI Mon Jan 25 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
192621 CFR 211.166(b)Adequate number of batches on stability
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews