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756490

Advance Pharmaceutical Inc — FEI 2434807

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 9, 2011
Fiscal Year
2012
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))
  • 923025 (VAI Fri Mar 06 2015 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
191821 CFR 211.166(a)(2)Stability sample storage conditions described
192021 CFR 211.166(a)(3)Valid stability test methods
192221 CFR 211.166(a)(4)Testing in same container - closure system
359121 CFR 211.110(b)In-process materials specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls
430921 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action