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1034994

Kath Khemicals LLC — FEI 3000719870

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 14, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Macomb, MI (United States)

Facility

Other inspections at this facility

  • 1265697 (OAI Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805646 (VAI Thu Nov 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699038 (VAI Wed Nov 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 554200 (VAI Tue Dec 30 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
202621 CFR 211.192Quality control unit review of records
344521 CFR 211.65(a)Equipment construction - reactive surfaces
363221 CFR 211.170(b)Annual visual exams of drug products
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
439121 CFR 211.180(e)(2)Items to cover on annual reviews