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814298

Shishuka Malhotra MD — FEI 3006028591

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 14, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
North Canton, OH (United States)

Additional Details

Clinical Investigator (CI)

Facility

Other inspections at this facility

  • 1202776 (NAI Fri Apr 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066601 (NAI Wed Sep 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 685130 (VAI Thu Oct 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 675722 (NAI Thu Aug 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
753021 CFR 312.62(b)Case history records- inadequate or inadequate
756021 CFR 312.60FD-1572, protocol compliance
756221 CFR 312.60Informed consent