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1018698

Genlabs Corporation — FEI 1000125638

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 21, 2017
Fiscal Year
2017
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))
  • 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))
  • 697468 (VAI Wed Nov 10 2010 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
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
188321 CFR 211.165(a)Testing and release for distribution
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
362921 CFR 211.170(b)Reserve samples identified, representative, stored