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608872

Sumitomo Pharma America, Inc. — FEI 1222021

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 1, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Marlborough, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1242239 (NAI Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161579 (NAI Fri Nov 05 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915063 (VAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843011 (VAI Fri May 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759431 (VAI Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports