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1288954

SOFIE Co. dba SOFIE — FEI 3003932395

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 28, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Houston, TX (United States)

Facility

Other inspections at this facility

  • 999635 (NAI Wed Jan 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977923 (VAI Fri May 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800995 (NAI Thu Sep 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1772321 CFR 212.10Personnel not qualified
1776321 CFR 212.20(d)Determination need for investigation
1781221 CFR 212.50Adequate controls (general)
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination