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1010916

Leading Pharma, LLC — FEI 3001611969

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 14, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Fairfield, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1251315 (VAI Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1129205 (NAI Tue Aug 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079111 (VAI Thu Jan 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067964 (NAI Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965261 (VAI Thu Mar 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
682921 CFR 314.80(c)(2)Failure to report non-alert ADEs
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications