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1118943

Owen Biosciences Inc. — FEI 1000132299

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 14, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Baton Rouge, LA (United States)

Facility

Other inspections at this facility

  • 1265549 (OAI Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985050 (VAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837816 (VAI Mon Jun 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 742136 (OAI Fri Aug 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 614208 (VAI Wed Sep 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
113421 CFR 211.25(b)Supervisor Training/Education/Experience
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
138421 CFR 211.101(c)Weighing/measuring/subdividing supervision
201121 CFR 211.188(a)Accurate reproduction
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
358221 CFR 211.105(a)Identification of containers, lines, equipment
434021 CFR 211.142Written warehousing procedures established/followed
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.