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1097437

MaxPax, LLC — FEI 2130094

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 25, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Elkhorn, WI (United States)

Facility

Other inspections at this facility

  • 931181 (VAI Wed Jun 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885213 (VAI Fri Jul 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 814003 (VAI Mon Jan 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752375 (VAI Mon Oct 31 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 604502 (VAI Fri Aug 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
187921 CFR 211.180(c)Records not made readily available to FDA
356721 CFR 211.84(d)(2)Component identification test