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1018414

Huvepharma, Inc. — FEI 1910641

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 14, 2017
Fiscal Year
2017
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Longmont, CO (United States)

Facility

Other inspections at this facility

  • 1087819 (VAI Tue Apr 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 952502 (VAI Fri Dec 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859555 (VAI Thu Dec 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769005 (VAI Tue Feb 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 669707 (NAI Wed Jun 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
191221 CFR 211.166(a)Written program not followed
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
356121 CFR 211.56(b)Written sanitation procedures lacking
358521 CFR 211.110(a)Control procedures to monitor and validate performance
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications