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1287690

ENDO USA, Inc. — FEI 1818977

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 20, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rochester, MI (United States)

Facility

Other inspections at this facility

  • 1202528 (VAI Fri Apr 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155650 (VAI Fri Oct 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086628 (VAI Mon Apr 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061939 (VAI Thu Aug 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007400 (VAI Mon Mar 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance