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748464

ONY Biotech, Inc. — FEI 1319086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 6, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Amherst, NY (United States)

Facility

Other inspections at this facility

  • 1250105 (OAI Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005033 (NAI Thu Mar 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946338 (VAI Fri Oct 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830440 (NAI Thu Apr 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697520 (NAI Tue Nov 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
438921 CFR 211.198(a)Procedures to be written and followed
682321 CFR 314.80(c)Failure by applicant to report ADE