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1250105

ONY Biotech, Inc. — FEI 1319086

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 26, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Amherst, NY (United States)

Facility

Other inspections at this facility

  • 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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
144821 CFR 211.111Establishment of time limitations
202721 CFR 211.192Investigations of discrepancies, failures
22921FDCA 582(b)(4)Systems in place to comply with verification requirements
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
356521 CFR 211.58Buildings not maintained in good state of repair