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931181

MaxPax, LLC — FEI 2130094

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 24, 2015
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Elkhorn, WI (United States)

Facility

Other inspections at this facility

  • 1097437 (VAI Thu Jul 25 2019 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
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
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
191421 CFR 211.166(a)Lack of written stability program
360321 CFR 211.160(b)Scientifically sound laboratory controls