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646629

Dixon Investments Inc — FEI 1037559

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 25, 2010
Fiscal Year
2010
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))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
136121 CFR 211.100(a)Absence of Written Procedures
191221 CFR 211.166(a)Written program not followed
191821 CFR 211.166(a)(2)Stability sample storage conditions described
197521 CFR 211.182Written records kept in individual logs
241921 CFR 211.198(a)Complaint Handling Procedure
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