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1073560

Epien Medical, Inc — FEI 3003428492

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
White Bear Lake, MN (United States)

Facility

Other inspections at this facility

  • 1280917 (VAI Thu Aug 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247073 (NAI Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072268 (NAI Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859099 (VAI Wed Dec 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730791 (NAI Wed Jun 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
184221 CFR 211.84(d)(1)Component identity verification
431421 CFR 211.84(d)(2)Reports of Analysis (Components)