Home / Inspections / 946338

946338

ONY Biotech, Inc. — FEI 1319086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 9, 2015
Fiscal Year
2016
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))
  • 830440 (NAI Thu Apr 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748464 (VAI Thu Oct 06 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697520 (NAI Tue Nov 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
241921 CFR 211.198(a)Complaint Handling Procedure
354821 CFR 211.46(c)Air filtration system lacking in production area