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923025

Advance Pharmaceutical Inc — FEI 2434807

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2015
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Holtsville, NY (United States)

Facility

Other inspections at this facility

  • 1262179 (VAI Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074294 (VAI Thu Dec 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017139 (VAI Thu Jul 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953151 (OAI Wed Dec 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859634 (VAI Thu Dec 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
202721 CFR 211.192Investigations of discrepancies, failures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include