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1214455

SOFIE Co — FEI 3008415560

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Totowa, NJ (United States)

Facility

Other inspections at this facility

  • 1020388 (NAI Wed Jun 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925779 (VAI Fri May 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800942 (NAI Thu Sep 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1790421 CFR 212.80(d)Labeling and product mix-ups
1791421 CFR 212.100(b)Complaint review
1794121 CFR 212.71(b)Documentation of Non-Conforming Product Investigation
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination