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668170

Sumitomo Pharma America, Inc. — FEI 1222021

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Marlborough, MA (United States)

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
202721 CFR 211.192Investigations of discrepancies, failures
438921 CFR 211.198(a)Procedures to be written and followed