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851401

ENDO USA, Inc — FEI 2410861

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 28, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rye, NY (United States)

Facility

Other inspections at this facility

  • 1288360 (NAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136893 (NAI Wed Mar 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963017 (NAI Wed Jan 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809209 (VAI Fri Dec 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 764681 (NAI Fri Jan 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
145121 CFR 211.113(b)Procedures for sterile drug products
189121 CFR 211.165(f)Failing drug products not rejected
682321 CFR 314.80(c)Failure by applicant to report ADE
891221 CFR 314.81(b)(2)Timely submission