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1265697

Kath Khemicals LLC — FEI 3000719870

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 3, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Macomb, MI (United States)

Facility

Other inspections at this facility

  • 1034994 (VAI Thu Dec 14 2017 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
136121 CFR 211.100(a)Absence of Written Procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
202021 CFR 211.188(b)(8)Labeling Control Records and Label Copies
202621 CFR 211.192Quality control unit review of records
439121 CFR 211.180(e)(2)Items to cover on annual reviews
900121 CFR 211.22(a)Lack of quality control unit