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1070156

Sparhawk Laboratories, Inc. — FEI 1910619

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 29, 2018
Fiscal Year
2019
Product Type
Veterinary
Project Area
Pre-Approval Eval. of Animal Drugs and Food Additives
Location
Lenexa, KS (United States)

Facility

Other inspections at this facility

  • 1276111 (VAI Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1272179 (OAI Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1199425 (VAI Mon Feb 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136995 (VAI Tue Mar 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122556 (OAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
145121 CFR 211.113(b)Procedures for sterile drug products
191421 CFR 211.166(a)Lack of written stability program
202821 CFR 211.192Extent of discrepancy, failure investigations
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls