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1164444

Episciences Inc — FEI 3006435842

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 11, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boise, ID (United States)

Facility

Other inspections at this facility

  • 1228002 (VAI Mon Jan 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012632 (VAI Fri May 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986392 (NAI Thu May 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923349 (OAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
183321 CFR 211.84(d)(1)Identity Testing of Each Component
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361621 CFR 211.165(d)Acceptance criteria for sampling & testing