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858927

Emilia Resources, LLC — FEI 3003982004

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 6, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
De Kalb, MS (United States)

Facility

Other inspections at this facility

  • 1099288 (VAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093368 (VAI Tue Jun 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866616 (NAI Tue Feb 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 675509 (VAI Wed Aug 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 616309 (VAI Wed Sep 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
109821 CFR 211.22(c)Approve or reject procedures or specs
116221 CFR 211.28(a)Protective Apparel Not Worn
126321 CFR 211.68(b)Computer control of master formula records
202621 CFR 211.192Quality control unit review of records
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360221 CFR 211.160(a)Deviations from laboratory control requirements