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1073264

Sofie Co dba Sofie — FEI 3004977184

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 3, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sterling, VA (United States)

Facility

Other inspections at this facility

  • 1276824 (VAI Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924228 (NAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 817083 (VAI Fri Feb 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 675342 (VAI Wed Aug 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1776421 CFR 212.20(e)Written QA procedures established, followed
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration