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1265549

Owen Biosciences Inc. — FEI 1000132299

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 27, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Baton Rouge, LA (United States)

Facility

Other inspections at this facility

  • 1118943 (VAI Fri Feb 14 2020 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
176721 CFR 211.137(a)Expiration date lacking
192221 CFR 211.166(a)(4)Testing in same container - closure system
203521 CFR 211.194(e)Stability testing records not included
360321 CFR 211.160(b)Scientifically sound laboratory controls