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697468

Genlabs Corporation — FEI 1000125638

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chino, CA (United States)

Facility

Other inspections at this facility

  • 1158526 (OAI Thu Dec 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018698 (VAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953128 (VAI Fri Dec 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760697 (VAI Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 569623 (NAI Thu Mar 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
181021 CFR 211.160(a)Lab controls established, including changes
188621 CFR 211.165(c)Sampling and testing plans not described
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
437821 CFR 211.188(b)(2)Identity of major equipment and lines used
439121 CFR 211.180(e)(2)Items to cover on annual reviews