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1235540

Bracco Diagnostics, Inc. — FEI 1000307800

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 27, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Princeton, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1012798 (VAI Mon Jun 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888857 (VAI Fri May 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837980 (OAI Thu Jun 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 792085 (VAI Fri Jul 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773087 (VAI Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report