Home / Inspections / 1158526

1158526

Genlabs Corporation — FEI 1000125638

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 9, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chino, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
121821 CFR 211.67(b)(1)Cleaning SOP/responsibility
188321 CFR 211.165(a)Testing and release for distribution
194321 CFR 211.180(e)(1)Review of representative number of batches
200421 CFR 211.184(d)Labeling: documentation of exam and review
361421 CFR 211.160(b)(4)Written calibration procedures
361621 CFR 211.165(d)Acceptance criteria for sampling & testing