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1282440

Generics Bidco II LLC — FEI 1038197

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Charlotte, NC (United States)

Facility

Other inspections at this facility

  • 1122274 (NAI Wed Mar 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063019 (NAI Fri Jul 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987950 (NAI Wed Aug 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942172 (NAI Thu Apr 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879391 (NAI Wed May 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures