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1279428

SOFIE Co. dba SOFIE — FEI 3006246010

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 7, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gilroy, CA (United States)

Facility

Other inspections at this facility

  • 1079123 (VAI Tue Feb 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982488 (VAI Thu Aug 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865698 (VAI Fri Feb 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1772321 CFR 212.10Personnel not qualified
1788221 CFR 212.70(d)(2)Data and documentation review
2137321 CFR 212.30(b)Equipment procedures