Home / Inspections / 742136

742136

Owen Biosciences Inc. — FEI 1000132299

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 19, 2011
Fiscal Year
2011
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))
  • 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))
  • 614208 (VAI Wed Sep 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
192621 CFR 211.166(b)Adequate number of batches on stability
194321 CFR 211.180(e)(1)Review of representative number of batches
197521 CFR 211.182Written records kept in individual logs
202621 CFR 211.192Quality control unit review of records
203321 CFR 211.194(c)Testing and standardization of standards et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
432521 CFR 211.110(a)Control procedures fail to include the following
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies