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1079123

SOFIE Co. dba SOFIE — FEI 3006246010

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 5, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gilroy, CA (United States)

Facility

Other inspections at this facility

  • 1279428 (VAI Thu Aug 07 2025 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
1786521 CFR 212.60(g)(5)Initials, signature, date
1788321 CFR 212.70(d)(3)Final dated signature
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination