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1263416

Dixon Investments Inc — FEI 1037559

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 11, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Orchard Hill, GA (United States)

Facility

Other inspections at this facility

  • 1083739 (VAI Fri Mar 22 2019 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
126321 CFR 211.68(b)Computer control of master formula records
192621 CFR 211.166(b)Adequate number of batches on stability
194321 CFR 211.180(e)(1)Review of representative number of batches
358521 CFR 211.110(a)Control procedures to monitor and validate performance