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953128

Genlabs Corporation — FEI 1000125638

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2015
Fiscal Year
2016
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))
  • 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
184221 CFR 211.84(d)(1)Component identity verification
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
204421 CFR 211.196Distribution Record Requirements
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
361321 CFR 211.160(b)(4)Establishment of calibration procedures
439121 CFR 211.180(e)(2)Items to cover on annual reviews