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1280917

Epien Medical, Inc — FEI 3003428492

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
White Bear Lake, MN (United States)

Facility

Other inspections at this facility

  • 1247073 (NAI Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073560 (VAI Thu Dec 06 2018 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113621 CFR 211.25(c)Inadequate number of personnel
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation