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1149844

Eagle Pharma Outsourcing LLC — FEI 3011688532

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 12, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hoover, AL (United States)

Facility

Other inspections at this facility

  • 1053615 (OAI Fri May 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942734 (OAI Fri Aug 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
200921 CFR 211.188Prepared for each batch, include complete information
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls