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923349

Episciences Inc — FEI 3006435842

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 10, 2015
Fiscal Year
2015
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))
  • 1164444 (OAI Fri Mar 11 2022 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))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
154021 CFR 211.125(a)Strict control not exercised over labeling issued
155021 CFR 211.125(f)Procedures Written and Followed
177721 CFR 211.150(b)Distribution Recall System
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
191421 CFR 211.166(a)Lack of written stability program
202621 CFR 211.192Quality control unit review of records
204421 CFR 211.196Distribution Record Requirements
358521 CFR 211.110(a)Control procedures to monitor and validate performance
438921 CFR 211.198(a)Procedures to be written and followed