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1046214

Oakwood Laboratories LLC — FEI 3003693370

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Solon, OH (United States)

Facility

Other inspections at this facility

  • 1238090 (VAI Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878903 (NAI Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797861 (VAI Thu Sep 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 776717 (NAI Thu Mar 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737421 (NAI Fri Jul 08 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
361621 CFR 211.165(d)Acceptance criteria for sampling & testing