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1098340

Norbrook Laboratories Limited — FEI 3005587188

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2019
Fiscal Year
2019
Product Type
Veterinary
Project Area
Bioresearch Monitoring
Location
Newry (United Kingdom)

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 1236307 (OAI Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155086 (VAI Fri Oct 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117113 (OAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1070719 (NAI Fri Sep 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 960695 (NAI Fri Mar 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
2153421 CFR 514.80(a)(1)Applicant did not establish/maintain/keep complete safety/effectiveness records
2154621 CFR 514.80(b)(4)Timely submission of Periodic drug experience report
2155121 CFR 514.80(b)(4)(iv)(B)Periodic report did not note adverse drug experiences in literature